Clinical trial NCT06915623: Gels to Treat and Prevent Gingival Inflammation Around Dental Implants
Official title: Nanocrystal Gels to Treat and Prevent Peri-implant Mucositis: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Peri-implant Mucositis
Healthy Peri-implant
Keywords: Peri-implant mucositis
clinical trial
pilot study
healthy peri-implant
bleeding on probing
nanocrystal gel
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Invicare Inc.
First posted: 2025-04-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: Received standard intervention and Gel intervention Control group: Received standard intervention
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding on probing (BOP)
timeFrame: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.
Secondary outcomes:
measure: Plaque index (PI)
timeFrame: It is assessed on intervention day and at a 4 week- follow up appointment
measure: Modified Gingival Index (MGI)
timeFrame: It is assessed on intervention day and at a 4 week- follow up appointment
measure: Probing Depth
timeFrame: It is assessed on intervention day and at a 4 week- follow up appointment
Other outcomes:
measure: Suppuration
timeFrame: It's assessed at the 4 week follow-up appointment.
measure: Irritation, Pain and Discomfort
timeFrame: This was reported at 7 days post-op.
Locations:
city: Québec City
country: Canada
facility: Faculté de Médecine dentaire de l'Université Laval
state: Quebec
Study officials:
affiliation: Laval University
name: Nancy Mouradian, DMD, MSc, FRCD(C), Dip.ABP
role: STUDY_DIRECTOR
affiliation: Laval University
name: Beatrice Groleau-Asselin, DMD, MSc, FRCD(C)
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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. 2024 Oct 3. doi: 10.1111/jopr.13961. Online ahead of print.
citation: 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.