NCT06820489 Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement
| NCT ID | NCT06820489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Bone Resorption |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-04-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage. 54 patients will be randomly assigned to either conventional connective tissue graft (C-CTG), scarf tissue graft (S-CTG) or dual zonde conept (DZ). Sealed envelopes are prepared for that purpose, of which 18 are internally labeled as C-CTG, 18 as S-CTG and 18 as DZ. Following IIP, a sealed envelope will be opened to reveal the treatment concept. Successful regeneration (primary outcome) is achieved when the combination of socket grafting and transmucosal augmentation (C-CTG or S-CTG or DZ) would be able to counteract any buccal soft tissue loss at level -1 mm. It is assessed on the basis of superimposed CBCTs taken pre-operatively and at one-year follow-up. Secondary outcomes include: horizontal buccal bone loss, vertical buccal bone loss, increase in buccal soft tissue thickness, patient-reported outcomes, plaque, bleeding on probing, probing depth, marginal bone loss, change in buccal soft tissue profile, midfacial soft tissue level, mesial and distal papilla level, Pink Esthetic Score.
Eligibility Criteria
Inclusion Criteria: * At least 20 years old * Good oral hygiene defined as full-mouth plaque score ≤ 25% * Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present * At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability * Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction * Written informed consent. Exclusion Criteria: * Pregnancy * Systemic diseases * Smoking; suppuration * \> 1 mm gingival asymmetry between the failing and contralateral tooth * Untreated periodontal disease * Untreated caries lesions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06820489 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Bone Resorption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06820489 currently recruiting?
Yes, NCT06820489 is actively recruiting participants. Contact the research team at vchristi.christiaens@UGent.be for enrollment information.
Where is the NCT06820489 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06820489 clinical trial?
NCT06820489 is sponsored by University Ghent. The trial plans to enroll 54 participants.