| NCT ID | NCT04741607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Esthetics |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2028-01-01 |
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 60 participants in total. It began in 2021-01-01 with a primary completion date of 2028-01-01.
⚠ 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 in need of a single implant in the premaxilla will be invited to participate in this multicenter 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 dimensions. 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 'delayed implant placement' and 5 with 'immediate implant placement'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction. In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed. In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface. A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later. Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site. Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.
Eligibility Criteria
Inclusion Criteria: * at least 18 years old * good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972) * presence of a single-rooted tooth in the anterior maxilla (15-25) 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 to ensure primary implant stability * intact or nearly intact buccal bone wall at the time of extraction (max 3 mm bone missing = max 6 mm distance from free gingival margin to buccal bone crest) Exclusion Criteria: * systemic diseases * smoking * untreated periodontal disease * untreated caries lesions
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04741607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esthetics. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04741607 currently recruiting?
Yes, NCT04741607 is actively recruiting participants. Contact the research team at jan.cosyn@ugent.be for enrollment information.
Where is the NCT04741607 trial being conducted?
This trial is being conducted at Ghent, Belgium, Liège, Belgium.
Who is sponsoring the NCT04741607 clinical trial?
NCT04741607 is sponsored by University Ghent. The trial plans to enroll 60 participants.