Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

April 4, 2025 updated by: Nancy Mouradian

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec City, Quebec, Canada, G1V 0A6
        • Faculté de Médecine dentaire de l'Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
This group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment.
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.
Active Comparator: Control group
This group only received standard mechanical debridement around implants.
Procedure: Mechanical Debridement
Cleaning and scaling of the implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BOP)
Time Frame: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.
A periodontal probe is gently inserted into the sulcus (the space between the implant and the surrounding gum tissue). The probe is moved around the implant in a sweeping motion, covering all surfaces (Mesial, Distal, Buccal and Palatal/Lingual). This gesture is done with light pressure to avoid causing unnecessary trauma to the tissues. After probing, the clinician observes the site for any bleeding. Bleeding that occurs within 10 to 15 seconds after probing is recorded as a positive BOP result.
First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index (PI)
Time Frame: It is assessed on intervention day and at a 4 week- follow up appointment

The plaque index is calculated by assigning a score to each surface based on the presence of plaque present, after probing. It is registered on the Mesial, Distal, buccal and palatal/lingual sides of the implant. Scores are reported dichotomously. It categorizes plaque as either present or absent, using a binary scoring system:

1: Presence of plaque 0: Absence of plaque A higher overall plaque score could indicate a worse outcome with a higher risk of inflammation of the tissues surrounding the implant.
It is assessed on intervention day and at a 4 week- follow up appointment
Modified Gingival Index (MGI)
Time Frame: It is assessed on intervention day and at a 4 week- follow up appointment
The testing was made similarly to the bleeding on probing, but also takes into consideration the visual evaluation of the tissues around the implant. The clinician focuses on detecting visual signs of inflammation, such as redness, swelling, and altered gingival contour. It is tested on the mesial, distal, buccal and palatal/lingual sides of the implant. Results are reported from a 0 to 4 scale with 0 indicating no bleeding and 4 indicating extreme inflammation with ulceration and tissue damage.
It is assessed on intervention day and at a 4 week- follow up appointment
Probing Depth
Time Frame: It is assessed on intervention day and at a 4 week- follow up appointment
It is measured using a UNC15 periodontal probe. It is gently inserted into the sulcus or pocket surrounding the implant, following the contours of the implant and tissue. Care is taken to avoid excessive pressure, which could damage the delicate peri-implant tissue or lead to inaccurate readings. It is assessed at the mesial, distal, buccal and palatal/lingual sides.
It is assessed on intervention day and at a 4 week- follow up appointment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suppuration
Time Frame: It's assessed at the 4 week follow-up appointment.
Presence or Absence were noted (qualitatively) 15 seconds after probing test.
It's assessed at the 4 week follow-up appointment.
Irritation, Pain and Discomfort
Time Frame: This was reported at 7 days post-op.

These are subjective outcomes reported by the patient by a questionnaire sent to them. Patients have to indicate from a scale of 0 to 10 :

  • Discomfort (0 is no discomfort and 10 is the worst discomfort)
  • Irritation (0 is no irritation and 10 is the worst irritation)
  • Pain (0 is no pain and 10 is the worst pain)
This was reported at 7 days post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nancy Mouradian

Collaborators

Invicare Inc.

Investigators

  • Study Director: Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP, Laval University
  • Principal Investigator: Beatrice Groleau-Asselin, DMD, MSc, FRCD(C), Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-257 A-3/13-04-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the patient consent form, possible IPD sharing was not disclosed. This might be considered in future trial registrations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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