Influence of Keratinized Mucosa on Dental Implants With Mucositis (NCT04874467) | Clinical Trial Compass
CompletedNot Applicable
Influence of Keratinized Mucosa on Dental Implants With Mucositis
Spain38 participantsStarted 2020-09-01
Plain-language summary
Introduction:
It seems that some local and systemic factors can be associated with an increased incidence of peri-implant diseases. Predisposing to an increase inflammatory response when plaque is present.
There is still controversy on which factors can be considered as risk indicators. One of them is the keratinized mucosa width (KM), that seems to facilitate plaque control around implants.
Objectives:
Assess the relationship between keratinized mucosa and the recurrence of mucositis, comparing bleeding on probing (BOP) in implants with mucositis for 24 weeks after implant disinfection therapy, the control group is defined by having KM ≥ 2 mm and the test group KM \< 2 mm.
Material and methods:
38 patients presenting one single implant each with a single screw retained crown loaded for at least 1 year. Periodontal maintenance therapy will be performed and oral hygiene instruction will be delivered. Follow up visits will be after 8, 12 and 24 weeks in which the following parameters will be registered: Keratinized Mucosa width, Attached mucosa, Gingival Index, Vestibule Depth, Mucosa Thickness. Probing Pocket Depth, Recession, modified Plaque Index, Bleeding on Probing, modified Bleeding Index. Also a microbiologic test will be taken in the implant sulcus before the periodontal maintenance therapy and at 24 weeks.
A multilevel statistical analysis will be conducted comparing the control and the test group, adjusting for the correlation among multiple observations.
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:
* patients\> 18 years;
* smokers \<10 cigarettes / day;
* partially edentulous patients. The spaces must be associated with at least one adjacent mesial and one distal tooth;
* presence of bleeding and / or suppuration on probing, erythema and inflammation;
* absence of radiographic bone loss around implant distance (\<2mm from expected radiographic marginal bone level);
* individual dental implants rehabilitated for more than a year;
* screw-retained restorations on implants;
* absence of active periodontal disease;
* who have not taken systemic antibiotics in the last 3 months;
* adequate oral hygiene motivation and collaboration defined as plaque index \<25%
Exclusion Criteria:
* totally edentulous patients;
* uncontrolled systemic diseases;
* diseases of the mucosa (erosive lichen planus, etc.);
* taking medications that may interfere with periodontal health or healing; (corticosteroids, calcium channel antagonists, antiepileptic drugs, immunosuppressants, etc.)
* pregnant or lactating patients;
* cemented implant restorations;
* restorations on implants over contoured that cannot be corrected.
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.