Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

NCT06915623 | Completed Early Phase 1

• 1 other identifier: 2021-257 A-3/13-04-2023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 1.Participants will visit the clinic and receive one of the two treatments randomly.
2. 2.One week later, they will complete a printed survey detailing any symptoms or discomfort experienced .
3. 3.After four weeks, participants will return to the clinic for checkups and tests to measure progress.

Conditions

Peri-implant Mucositis; Healthy Peri-implant

Keywords

Peri-implant mucositis; clinical trial; pilot study; healthy peri-implant; bleeding on probing; nanocrystal gel

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BOP)

  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 Outcomes (3)

• Plaque index (PI)

  It is assessed on intervention day and at a 4 week- follow up appointment

• Modified Gingival Index (MGI)

  It is assessed on intervention day and at a 4 week- follow up appointment

• Probing Depth

  It is assessed on intervention day and at a 4 week- follow up appointment

Other Outcomes (2)

• Suppuration

  It's assessed at the 4 week follow-up appointment.

• Irritation, Pain and Discomfort

  This was reported at 7 days post-op.

Study Arms (2)

Test Group

EXPERIMENTAL

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

Drug: Innovative Gel application; Procedure: Mechanical Debridement

Control group

ACTIVE COMPARATOR

This group only received standard mechanical debridement around implants.

Procedure: Mechanical Debridement

Interventions

Innovative Gel application DRUG

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

Test Group

Mechanical Debridement PROCEDURE

Cleaning and scaling of the implant.

Control group; Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nancy Mouradian: lead
• Invicare Inc.: collaborator

Study Sites (1)

Faculté de Médecine dentaire de l'Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (5)

• Tamimi F, Le Nihouannen D, Bassett DC, Ibasco S, Gbureck U, Knowles J, Wright A, Flynn A, Komarova SV, Barralet JE. Biocompatibility of magnesium phosphate minerals and their stability under physiological conditions. Acta Biomater. 2011 Jun;7(6):2678-85. doi: 10.1016/j.actbio.2011.02.007. Epub 2011 Feb 13.

  PMID: 21324383 BACKGROUND

• Laurenti M, Al Subaie A, Abdallah MN, Cortes AR, Ackerman JL, Vali H, Basu K, Zhang YL, Murshed M, Strandman S, Zhu J, Makhoul N, Barralet JE, Tamimi F. Two-Dimensional Magnesium Phosphate Nanosheets Form Highly Thixotropic Gels That Up-Regulate Bone Formation. Nano Lett. 2016 Aug 10;16(8):4779-87. doi: 10.1021/acs.nanolett.6b00636. Epub 2016 Jul 6.

  PMID: 27280476 BACKGROUND

• Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.

  PMID: 25123773 BACKGROUND

• Behmanesh S, Chow K, Dondani J, Al-Hashedi A, Tamimi F. Effectiveness of 2D magnesium phosphate hydrogel for surgical decontamination of dental implants: A case series. J Prosthodont. 2025 Jun;34(5):449-455. doi: 10.1111/jopr.13961. Epub 2024 Oct 3.

  PMID: 39363547 BACKGROUND

• Al-Hashedi AA, Laurenti M, Benhamou V, Tamimi F. Decontamination of titanium implants using physical methods. Clin Oral Implants Res. 2017 Aug;28(8):1013-1021. doi: 10.1111/clr.12914. Epub 2016 Jul 8.

  PMID: 27392811 BACKGROUND

Study Officials

• Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP

  Laval University

  STUDY DIRECTOR

• Beatrice Groleau-Asselin, DMD, MSc, FRCD(C)

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

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

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 8, 2025
• Study Start: June 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)