Soft Tissue Management in Peri-Implant Regions (NCT06880185) | Clinical Trial Compass
CompletedNot Applicable
Soft Tissue Management in Peri-Implant Regions
Turkey (Türkiye)20 participantsStarted 2023-12-01
Plain-language summary
Background:This study aimed to compare the effect of ribose cross-linked thick collagen membrane (RCCM) with that of subepithelial connective tissue graft (CTG) in sites with soft tissue deficiency in the horizontal aspect around the implant.
Methods:Single implant sites were included in the study of 20 systemically healthy patients. All procedures were performed concurrently with implant placement; SCTG was administered in ten patients, and RCCM in the other ten. Before the operation, the PIMT and peri-implant mucosa width (PIMW) were measured. Visual analog scale (VAS) and Oral Health Impact profile-14 (OHIP-14) scores were recorded on post-operative days 1, 3, and 7. At 1 and 3 months measurements were repeated.
Results:In terms of PIMT, an average increase of 1.87 mm was recorded in the RCCM group and 1.99 mm in the SCTG group. The rate of increase in PIMT was statistically similar in both the groups (p\>0.05). The OHIP-14 and VAS scores were similar between the groups on days 1, 3, and 7. There was a decrease at 3 months in both the groups.
Conclusion:Within the limits of this study, RCCM provided a similar increase in PIMT as SCTG. RCCM is a promising alternative to SCTG for increasing the PIMT.
Keywords: Collagen, Connective tissue, Dental implants, Oral mucosa
Who can participate
Age range
18 Years – 60 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:
* Systemically healthy
* The edentulous space for which implant treatment is planned to be single tooth size and molar tooth site
* Those with soft tissue deficiency in the horizontal aspect in the site where implant treatment is planned
* Age between 18-60 years
* Does not have a condition that may cause a bleeding disorder
* No nausea-vomiting reflex
* Patients with good oral hygiene
Exclusion Criteria:
* Patients with systemic disorders (diabetes, hypertension, radiotherapy/ chemotherapy, etc.)
* Patients who have insufficient horizontal alveolar bone in the site where implant treatment is planned and who may lead to bone dehiscence after implant placement
* Patients with collagen allergy
* Those taking any medication that may affect wound healing
* Those with bleeding disorders
* Smokers who smoke more than 10 cigarettes a day
* Poor oral hygiene
* Those with vomiting-nausea reflex
* Allergic to anti-inflammatory drugs
* Patients with pregnancy/breastfeeding status.
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.