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Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Summary
The aim of this study is to assess whether and how a mouthwash containing an ingredient that reduces inflammation in combination with a recently developed treatment is more effective at improving advanced gum disease. Advanced gum disease, also called periodontitis, is an inflammation of the gums which results in decrease in bone levels supporting teeth and can result in tooth loss. Minimally invasive non-surgical treatment (MINST) is a type of deep cleaning of teeth which involves removal of plaque beneath the gum margin and reduces inflammation. In this trial we will assess the additional benefits of combining deep cleaning (MINST) with the use of a mouthwash known to have a beneficial effect on tissue healing by helping the body to 'switch off' inflammation in periodontitis. Participants may be part of a control group, where you they be treated by MINST and provided with a placebo mouthwash The placebo mouthwash does not contain the active ingredient which reduces inflammation. Neither the participants nor the investigators can decide or be aware of which mouthwash the participants be given, as this will be determined randomly and the two mouthwash packages look the same. The duration of the study will be over six months and will consist of a total of seven appointments. The aim of this study is to assess whether we can achieve better outcomes using this mouthwash and the healing of thegums will be assessed clinically. In addition, other parameters such as saliva samples, blood samples and plaque samples will be collected throughout the study, which allows us to examine the healing process in more detail and will help us understand how exactly the combination of MINST and the mouthwash improve healing.
Official title: Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-11-01
Completion Date
2027-05-01
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash
adjunctive anti-inflammatory mouthwash
Placebo mouthwash
Contains all the inactive ingredients as the test mouthwash without the LXA4
Locations (1)
Oral Clinical Research Unit (OCRU) at King's College London (KCL)
London, United Kingdom