Gels to Treat and Prevent Gingival Inflammation Around Dental Implants (NCT06915623) | Clinical Trial Compass
CompletedEarly Phase 1
Gels to Treat and Prevent Gingival Inflammation Around Dental Implants
Canada8 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bleeding on probing (BOP)
Timeframe: First assessment is the day of the intervention and the last one is 4 weeks later at follow-up.