Clinical Research Directory

Turtle-Assisted Animal Interaction on Dental Anxiety and Physiological Parameters in Children

This study aims to measure the effect of a structured AAT session with a turtle present on dental anxiety and behavioral compliance in children during routine procedures that do not require local anesthesia in a pediatric dental clinic.

Passiflora Incarnata for Dental Extraction Anxiety

This study looks at whether Passiflora incarnata (passionflower extract) can help reduce anxiety before tooth extraction. Male participants who feel high anxiety before the procedure will receive either passionflower extract or an inactive substance (placebo) before their extraction. Neither the participants nor the researchers will know who receives which one. The study will compare anxiety levels using a questionnaire, along with body responses such as heart rate and blood pressure. The goal is to find out whether this natural option could help patients who fear tooth extraction, without the use of medication

Acupressure and Hand Massage for Reducing Anxiety During Dental Local Anesthetic Injections in Children

This study aims to compare the effects of acupressure ,hand massage , and routine behavioral management on anxiety in children undergoing dental local anesthetic injections . Anxiety will be evaluated using Venham Picture Test ( VPT ) and heart rate measurements at specified time points before , during and after the injection procedure .

Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction

Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.

Effect of Dental Anxiety Management by Integrative Music-mindfulness Intervention Among Iraqi Adult Patients in a Karbala City Private Clinic, an RCT Study

Dental anxiety considered as one of the weariest problems and disturbing problems with which the individual dentist has had to fight. Dental anxiety has been a major patient's complaint which interferes with different dental treatment. Therefore, dental anxiety may have a critical impact on the deterioration of oral health. It is a problem of many patients. Excessive dental anxiety will leads to bad oral health. It is estimated that about 36% of the world population are suffering from dental anxiety and 5- 15% of adults in developed countries suffer from severe anxiety to dental treatment. According to researchers, between 50% and 80% of adults in the United States have some degree of dental anxiety. In Saudi Arabia dental anxiety was found to be 50%. Very limited number of studies have been done in Iraq especially management of anxiety, for example in Baghdad, it was found that about 55% of study population had dental anxiety. Because of no studies have been conducted to determine the impact of dental anxiety management in Karbala city-Iraq, thus conducting such a study is timely and much needed to improve patient care. The goal of this clinical trial is to test the effectiveness of behavioral management technique on patients having different levels of dental anxiety, among Iraqi adult patients seeking private dental care in Karbala city. The main question it aims to answer is: Is dental anxiety management effective in decreasing dental anxiety levels among adult Iraqi patients seeking private dental care in Karbala city? Participants will be requested to fill the self-reported questionnaire paper for anxiety levels determination \& sociodemographic factors. Researchers will use non-pharmacological behavioral therapeutic techniques including combination of music therapy (distraction technique) and mindfulness therapy (relaxation breathing and muscle relaxation techniques) applied as one package. the patients with anxiety will be divided in to 2 groups; one group with applying intervention and the other group without applying intervention to see if the dental anxiety therapy is effective in decreasing dental anxiety level for anxiety patient. This study hypothesized that there is a significant difference in the changes of dental anxiety level between managed patients and not managed patients (between group) and (within group) between pre and post managed patients after three months follow up assessment.

Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.

Virtual Reality During Periodontal Frenectomy

The goal of this clinical trial is to learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure. The main questions it aims to answer are: Does virtual reality reduce anxiety before and after periodontal frenectomy? Does virtual reality reduce pain during and after the procedure? Does virtual reality have a favorable effect on physiological stress responses such as blood pressure, heart rate, and oxygen saturation? Does virtual reality affect surgical process-related outcomes and early wound healing? Researchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality. Participants will: Complete anxiety and pain questionnaires before the procedure. Undergo periodontal frenectomy under local anesthesia. Be randomly assigned to either the virtual reality group or the control group. Have blood pressure, heart rate, oxygen saturation, and pain levels recorded at defined time points during the procedure. Record daily pain levels and analgesic use for 7 days after surgery. Return for a 7-day follow-up visit for suture removal and early wound healing assessment.

Effects of Preoperative Information Formats in Third Molar Surgery

This study evaluates whether physician-guided visual information provided before impacted mandibular third molar surgery can improve hemodynamic stability during the perioperative period. Participants are assigned to one of three preoperative information methods: standard verbal information, real surgical video information, or 3D animation video information. Changes in systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation are assessed at multiple perioperative time points to determine whether visual information reduces stress-related physiologic responses. The study also examines whether these information methods influence preoperative dental fear.

Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM

The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability. In the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure. Perioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and short version of the CEDAM (CEDAM-8). A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.

Effects of Topical Anesthetics on Pain and Anxiety in Children

Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited. This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes. Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.

Effectiveness of Virtual Reality Technique on Children

Studying the effect of using virtual reality technique in managing pain, anxiety, and vital signs among pediatric dental patients.

Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent.

The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is: Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well. Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.

Storybook and Animation Video Adjuncts to Tell-Show-Do in Pediatric Dentistry

This study is designed to evaluate strategies for reducing dental anxiety in pediatric patients. The commonly applied "Tell-Show-Do" method involves explaining and demonstrating dental procedures before they are performed. In this randomized controlled trial, three groups of children will be compared: Children who receive only the Tell-Show-Do method, Children who are prepared at home with a storybook prior to receiving the Tell-Show-Do method, Children who are prepared at home with an animation video prior to receiving the Tell-Show-Do method. Children's dental anxiety will be assessed using validated behavioral observation scales, including baseline measurement at the first examination, after preparation, and following completion of dental treatment. The study will determine whether the addition of a storybook or an animation video provides greater effectiveness in reducing dental anxiety compared with the Tell-Show-Do method alone.

The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial

The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction. Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.

Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction

The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain in patients with moderate to severe dental anxiety undergoing mandibular third molar extraction. The main questions it aims to answer are: * Do aromatherapy and music therapy improve physiological responses during mandibular third molar extraction? * Are there differences between aromatherapy and music therapy in their effects on physiological parameters and intraoperative pain during mandibular third molar extraction? Researchers will compare an aromatherapy group and a music therapy group with a control group to determine whether these interventions improve physiological responses and reduce intraoperative pain. Participants will: * Complete the Modified Dental Anxiety Scale (MDAS) before surgery to determine eligibility. * Receive aromatherapy, music therapy, or standard care for five minutes before the surgical procedure. * Undergo measurement of blood pressure, heart rate, and oxygen saturation before and after surgery. * Report intraoperative pain using a visual analog scale (VAS).

Effect of Music Listening on Anxiety During Diode Laser Frenectomy

This randomized controlled trial evaluated the effect of music listening on anxiety, stress, and pain in patients undergoing diode laser frenectomy. Participants were adults aged 18 to 65 years who were scheduled to receive frenectomy as part of their routine periodontal treatment. Participants were allocated into two groups: a music group, in which patients listened to a pre-recorded music performance during the procedure, and a control group, in which patients received the routine procedure without music. Anxiety and stress levels were assessed using validated questionnaires before and after the procedure. Postoperative pain was evaluated using a visual analogue scale. In the music group, patients also completed an additional questionnaire about their experience with music during the procedure. The study aimed to determine whether listening to music during frenectomy could improve patient comfort by reducing anxiety, perceived stress, and pain.

Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation

The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.

Reducing Pain During Dental Nerve Block Injections in Children

Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and teeth in children. Many children find this injection very painful and scary. Bad experiences can make them afraid of the dentist for years. This study was designed to test different ways to make the injection less painful and stressful for children. What did the researchers want to find out? They planned to compare three different methods to see which one works best to reduce pain, distress, and physical signs of fear (like a fast heartbeat) during the injection: External cooling + vibration (using a special device that cools and vibrates on the skin near the injection site) Counterstimulation (gentle tapping or pressing with a cotton roll near the injection site) A thinner needle (30-gauge instead of the standard 27-gauge) Standard method (27-gauge needle with no extra distraction) - this is the control group Who took part? The study enrolled 166 healthy children between the ages of 5 and 9 years who needed a lower jaw dental injection at Al-Mustansiriyah University Dental College. What happened during the study? Children were randomly placed into one of the four groups. All children received the same numbing medicine (2% lidocaine with epinephrine). Dentists gave the injection at the same speed for everyone. Researchers planned to measure: How much pain the child felt (using the Wong-Baker Faces scale, where children point to a face showing their pain level) How much pain the child showed (using the FLACC scale, which looks at face, legs, activity, crying, and comfort) Heart rate and oxygen level (using a finger clip device) How well the child cooperated (using the Frankl Behavior Rating Scale) What outcomes are being measured? The primary outcomes are children's self-reported pain and observer-rated pain behavior. Secondary outcomes include physiological responses (heart rate and oxygen saturation) and behavioral cooperation scores. The study will compare changes in these measures across the four intervention groups. What is the purpose of this research? The findings from this trial are expected to provide evidence to help dentists choose the most effective comfort measures to keep children calm and pain-free during lower jaw injections. The study aims to clarify whether distraction-based methods (cooling+vibration or counterstimulation) offer advantages over simply changing the needle gauge. Were there any side effects or risks? Safety is being monitored continuously throughout the procedure via pulse oximetry (oxygen saturation) and heart rate tracking. The interventions are considered low-risk, and children who show excessive distress are withdrawn and managed according to standard care. Who paid for this study? The study received no outside funding. The authors declared no conflicts of interest. Where was the study done? Department of Pediatric Dentistry, Al-Mustansiriyah University, Baghdad, Iraq.

The Effect of Music That the Individuals With Moderate Dental Anxiety Have Started Listening to While Waiting

It is aimed to evaluate the effect of music listened to in the waiting room on patients with moderate dental anxiety during the restoration of posterior occlusal dental caries on vital signs, cortisol and oxytocin levels of the participants.

Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie

The vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. This clinical study examines the application of hypnosis delivered through immersive virtual reality (VR) for anxious children ongoing dental procedures. The investigators will explore whether VR is as effective on pain and anxiety relief as a pharmacological sedation with inhalation of nitrous oxide.

Comparasion of Dental Anxiety in First Time Complete Denture Patients

This quasi-experimental study compares dental anxiety levels in edentulous patients at two specific clinical points: the primary impression appointment and the denture insertion appointment. The study aims to determine if the process of receiving first-time complete dentures significantly impacts patient anxiety levels. Data will be collected from 70 participants at the Khyber College of Dentistry over a five-week interval between the two appointments

Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia

This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children. Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order. Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded. The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.

Impact of Dental Anxiety Coping Module on Children With Dental Anxiety

The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are: 1. Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback? 2. Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS? 3. Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?

Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: * Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? * How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? * Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.