Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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

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Peri-implant Mucositis Healthy Peri-implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Test group: Received standard intervention and Gel intervention Control group: Received standard intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test Group

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

Group Type EXPERIMENTAL

Innovative Gel application

Intervention Type DRUG

Innovative gel application: Gel is applied as an adjunct treatment to cleaning and scaling.

Mechanical Debridement

Intervention Type PROCEDURE

Cleaning and scaling of the implant.

Control group

This group only received standard mechanical debridement around implants.

Group Type ACTIVE_COMPARATOR

Mechanical Debridement

Intervention Type PROCEDURE

Cleaning and scaling of the implant.

Interventions

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Innovative Gel application

Innovative gel application: Gel is applied as an adjunct treatment to cleaning and scaling.

Intervention Type DRUG

Mechanical Debridement

Cleaning and scaling of the implant.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No