Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

Nancy Mouradian

Status and phase: Completed; Early Phase 1

Conditions: Peri-implant Mucositis; Healthy Peri-implant

Treatments: Procedure: Mechanical Debridement; Drug: Innovative Gel application

Study type: Interventional

Funder types: Other

Identifiers

NCT06915623

2021-257 A-3/13-04-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or older
• Maxillary or mandibular fixed implant-supported prostheses (up to 3 units)
• Diagnosis of peri-implant health or peri-implant mucositis
• Signed an informed consent form

Exclusion criteria

• Advanced peri-implantitis
• Extensive implant-supported restorations (four units or more)
• Recent radiotherapy, chemotherapy, long-term systemic corticosteroid therapy
• Drugs inducing gingival hyperplasia
• Recent antibiotics (within three months)
• Prosthetic restorations impeding clinical assessment
• Poor marginal contours or prosthetic complications
• Peri-implant bone loss exceeding 30%
• Acute oral infection
• Uncontrolled diabetes, systemic diseases, immune deficiency, autoimmune disease
• Long-term bisphosphonate use

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Test Group

Experimental group

Description:

This group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment.

Treatment:

Drug: Innovative Gel application

Procedure: Mechanical Debridement

Control group

Active Comparator group

Description:

This group only received standard mechanical debridement around implants.

Treatment:

Procedure: Mechanical Debridement