CTG vs VCMX for Peri-implant Soft Tissue Thickness (NCT07324187) | Clinical Trial Compass
CompletedNot Applicable
CTG vs VCMX for Peri-implant Soft Tissue Thickness
Poland36 participantsStarted 2022-01-02
Plain-language summary
This investigator-initiated randomized controlled clinical trial evaluated changes in peri-implant soft tissue thickness in the aesthetic zone following soft tissue augmentation. Adult patients requiring single-tooth implant therapy in the aesthetic zone were randomly assigned to receive either an autogenous connective tissue graft (CTG) or a volume-stable collagen matrix (VCMX) at the implant site.
The primary objective of the study was to compare changes in peri-implant soft tissue thickness between the two treatment approaches over time. Secondary objectives included evaluation of aesthetic outcomes, clinical parameters, and treatment-related complications.
The study was conducted at a single academic clinical center in Poland in accordance with Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements. All participants provided written informed consent prior to enrollment.
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:
* Adults aged 18 years or older.
* Single-tooth edentulism in the aesthetic zone of the maxilla or mandible, bordered by natural teeth on both sides.
* Bilateral two-tooth edentulism accepted only when implants were placed in separate quadrants.
* Indication for dental implant placement with peri-implant soft tissue augmentation.
* Adequate bone volume at the implant site confirmed radiographically.
* Baseline peri-implant soft tissue thickness suitable for augmentation.
* Minimum height of keratinized tissue of at least 2 mm.
* Good oral hygiene and periodontal health.
* Ability and willingness to provide written informed consent.
Exclusion Criteria:
* Previous bone grafting procedures at the intended implant site.
* Severe periodontal disease or untreated oral infection.
* Bruxism or heavy smoking.
* Systemic diseases or conditions that could impair wound healing or bone metabolism.
* History of radiotherapy in the head and neck region.
* Previous or ongoing bisphosphonate therapy.
* Uncontrolled diabetes mellitus.
* Pregnancy or breastfeeding.
* Use of medications known to interfere with soft tissue healing.
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
Change in peri-implant soft tissue thickness
Timeframe: Baseline and 6 months after soft tissue augmentation