Active — Not RecruitingNot Applicable

Connective Tissue Graft Versus Collagen Matrix

Belgium60 participantsStarted 2019-09-01

Plain-language summary

Patients in need of a single implant in the premaxilla and presenting with a horizontal buccal soft tissue defect at the single tooth gap will be invited to participate in a multicenter RCT. Prior to surgery, a small-field low-dose CBCT is taken since a buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap is required to ensure complete embedding of an implant by bone. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'test group' and 5 with 'control group'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated. In the control group, a single implant is placed following flap elevation and surgical guide installation. Then, a CTG from the palate is positioned under the buccal mucosa to thicken the tissues. A provisional restoration is placed at the day of surgery, which is replaced by a permanent one 3m later. Patients in the test group are treated in the same way, yet a CM (Fibro-Gide®) is used instead of a CTG. Changes in the buccal soft tissue profile are registered over time by superimposing intra-oral scans in SMOP® software. Secondary outcomes included clinical, aesthetic and patient-reported outcomes.

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: * at least 18 years old * good oral hygiene defined as full-mouth plaque score ≤ 25% * presence of a single tooth gap in the anterior maxilla (15-25) with both neighboring teeth present * failing tooth at least 3 months earlier removed * class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) * buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone. Exclusion Criteria: * systemic diseases * smoking * (history of) periodontal disease; * untreated caries lesions * need for horizontal bone augmentation at the time of implant placement

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

Changes in buccal soft tissue profile (BSP)

Timeframe: Pre-op, 3 months, 1 year, 2 years

Trial details

NCT IDNCT04210596

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Buccal Soft Tissue Profile (BSP) trials