NCT07203872

Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

Adjunctive Inflammation-resolution Therapy in Minimally-invasive Treatment of Deep Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a pilot randomised controlled trial comparing patients being treated with MINST non-surgical therapy with an adjunctive test or placebo mouthwash. This will be a single centre trial in the Department of Periodontology at Guy's Dental Hospital. Patients will be recruited and treated at this centre as per the inclusion criteria. The primary outcome is PPD reduction at 6 months in test vs control group, and the secondary outcomes are CAL reduction at 6 months, changes in inflammatory/tissue degradation/repair biomarkers in saliva and GCF between baseline and 6 months post-treatment.

Conditions

• Periodontal Diseases
• Periodontitis

Interventions

Type	Name	Description
DEVICE	IsoDent Paro Strong (Isodent Ltd. Valtakatu 4 D, 96100 Rovaniemi, Finland) mouthwash	adjunctive anti-inflammatory mouthwash
DEVICE	Placebo mouthwash	Contains all the inactive ingredients as the test mouthwash without the LXA4

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-10-02
• Last updated: 2025-10-02

Locations

1 site across 1 country: United Kingdom