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Peri-implant MucositisEarly Phase 1NCT06915623

Gels to Treat and Prevent Gingival Inflammation Around Dental Implants

A Early Phase 1 study testing Innovative Gel application and Mechanical Debridement in people with Peri-implant Mucositis and Healthy Peri-implant, run by Nancy Mouradian at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peri-implant Mucositis, Healthy Peri-implant
What is being tested?
Innovative Gel application and Mechanical Debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteCanada
Study dates
1 Jun 2023to 31 Jul 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

Canada1 site

  • Faculté de Médecine dentaire de l'Université Laval

    Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

Official title: 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?

Read more

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.
Read the 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.

Being tested
Innovative Gel application, Mechanical Debridement
Keywords
Peri-implant mucositis, clinical trial, pilot study, healthy peri-implant, bleeding on probing, nanocrystal gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Innovative Gel applicationDrug

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

  • Mechanical DebridementProcedure or surgery

    Cleaning and scaling of the implant.

Study groups in NCT06915623
Study groupRoleWhat they receive
Test GroupExperimentalThis group received standard mechanical debridement around the implants with a nanocrystal gel administered topically as an adjunct treatment.
Receives: Drug: Innovative Gel application; Procedure: Mechanical Debridement
Control groupActive comparatorThis group only received standard mechanical debridement around implants.
Receives: Procedure: Mechanical Debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.

Secondary outcomes (3)

  1. Plaque index (PI)

    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.

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

  2. Modified Gingival Index (MGI)

    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.

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

  3. Probing Depth

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start1 Jun 2023
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Test group: Received standard intervention and Gel intervention Control group: Received standard intervention
Masking
Single blind
Who is masked
Participant
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915623
Sponsor's protocol ID
2021-257 A-3/13-04-2023
Status last verified
Apr 2025
First submitted
28 Mar 2025
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In the patient consent form, possible IPD sharing was not disclosed. This might be considered in future trial registrations.

Publications

  • 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.

    PubMed 21324383

  • 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.

    PubMed 27280476

  • 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.

    PubMed 25123773

  • 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.

    PubMed 39363547

  • 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.

    PubMed 27392811

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Innovative Gel application and Mechanical Debridement in people with Peri-implant Mucositis and Healthy Peri-implant, run by Nancy Mouradian at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915623, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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