NCT06915623

Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

Nanocrystal Gels to Treat and Prevent Peri-implant Mucositis: A Randomized Controlled Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Nancy Mouradian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate a gel's potential to improve gum health around dental implants when used alongside traditional cleaning methods. The central research question is: Does the gel reduce gum bleeding? Researchers will compare the effects of traditional dental cleaning alone wit those of dental cleaning combined with gel administration, focusing on overall gum health around implants. The study will enroll eight participants-some with early gum issues, such as bleeding gums, and others with healthy gums. Each participant will be randomly assigned to receive either regular dental cleaning or the cleaning paired with gel application. The study process includes the following steps: 1. Participants will visit the clinic and receive one of the two treatments randomly. 2. One week later, they will complete a printed survey detailing any symptoms or discomfort experienced . 3. After four weeks, participants will return to the clinic for checkups and tests to measure progress.

Detailed description

This clinical study, conducted at Laval University's graduate periodontics clinic, investigates the efficacy and safety of a nanocrystal gel as a supplementary treatment to non-surgical mechanical debridement (professional cleaning) for managing peri-implant mucositis-a reversible inflammatory condition affecting the soft tissues around dental implants. The study enrolls eight participants, comprising individuals with either healthy peri-implant tissues or peri-implant mucositis. Participants are randomly assigned to one of two groups: the test group receives the nanocrystal gel in conjunction with standard peri-implant therapy, while the control group undergoes peri-implant therapy alone. The primary focus of the investigation is the bleeding on probing (BoP) parameter, analyzing its progression over a four-week period and comparing outcomes between the two groups. Additionally, other clinical parameters, including the modified gingival index, modified plaque index, and pocket depth, are evaluated. Participants receive one of the designated treatments, with the study design ensuring they are blinded to the specific treatment administered. A follow-up appointment four weeks later allows for the reassessment of all recorded clinical parameters. One week after treatment, participants complete a survey to report any discomfort or pain experienced post-treatment.

Conditions

• Peri-implant Mucositis
• Healthy Peri-implant

Interventions

Type	Name	Description
DRUG	Innovative Gel application	Innovative gel application: Gel is applied as an adjunct treatment to cleaning and scaling.
PROCEDURE	Mechanical Debridement	Cleaning and scaling of the implant.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Canada