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NCT06897085

Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in Supraosseous Periodontal Defects Treated with the Single Flap Approach

Sponsor: Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy

View on ClinicalTrials.gov

Summary

Treatment of supraosseous defects (SD) may be challenging due to their limited regenerative potential. When located in aesthetic areas, treatment may result in a gingival recession increase with consequent patients' concerns in terms of aesthetic or tooth sensibility. In the present study, a minimally-invasive surgical procedure (namely, the Single Flap Approach, SFA) will be combined with the application of a viscoelastic gel containing polynucleotides and hyaluronic acid that was reported to positively modulate periodontal wound healing. The outcomes, evaluated 6 months after treatment, will be compared to those obtained with SFA alone. The evaluated outcomes will be either clinical (evaluation of clinical parameters such as gingival recession, residual probing depth, clinical attachment gain) or related to patient's perception (such as evaluation of the aesthetic or tooth sensibility).

Official title: Efficacy of a Gel Containing Polynucleotides and Hyaluronic Acid in the Treatment of Periodontal Supraosseous Defects with the Single Flap Approach: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2026-12-30

Last Updated

2025-04-01

Healthy Volunteers

Conditions

Periodontitis Gingival Recession, Localized Aesthetic Perception Aesthetic Outcomes

Interventions

DEVICE

viscoelastic gel containing polynucleotides and hyaluronic acid

Defects randomized to "test treatment" will receive a viscoelastic gel containing polynucleotides and hyaluronic acid (PN-HA gel) immediately at the completion of intra-surgical instrumentation. PN-HA gel will be also applied on the surgical wound at the completion of the suturing phase.

OTHER

No intervention

Defects randomized to "control group" will be accessed with the SFA and no PN-HA gel will be applied.

INCLUSION CRITERIA Patient-specific * age≥ 18 years; * diagnosis of Stage III or IV periodontitis22; * good physical status (ASA1 and ASA2 according to Physical Status Classification System); * systemic and local conditions compatible with periodontal surgical procedures; * patient willing and fully capable to comply with the study protocol. Site-specific * defect located in an incisor, canine or premolar region which becomes exposed during spontaneous smiling; * defect with an intrabony component (as assessed on periapical radiograph and confirmed intra-surgically) ≤ 2 mm; * defect with a radiographic CEJ-BC≥ 4 mm; d) residual (following step I-II of treatment) PD≥6 mm at both interproximal aspects facing the SD. EXCLUSION CRITERIA Patient-specific * poorly controlled diabetes (HbA1C ≥ 7%); * history of radiation therapy in the head and neck area; * history of chemotherapy; * systemic disease or conditions with a documented effect on bone metabolism and/or periodontal status/healing; * past (within 6 months prior to enrollment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or periodontal status/healing; * physical or mental handicap that can interfere with adherence to the study procedures and adequate hygienic compliance; * documented allergy to dental materials involved in the experimental protocol; * pregnancy or lactation; * history of drug or alcohol abuse. Moreover, participants will be immediately excluded from the study: * upon request to withdraw from further participation; * development of acute dental/periodontal or oral conditions requiring treatment; * development of conditions conflicting with the exclusion criteria listed above * failure to comply with study instructions/requirements. Site-specific * presence of untreated endodontic lesions or inadequate endodontic treatment of teeth facing the SD; * presence of orthodontic appliances; * local conditions preventing proper plaque control at experimental sites; * grade III mobility.