About this trial
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
Qualifiers
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
Disqualifiers
systemic diseases
smoking
untreated periodontal disease
untreated caries lesions
Trial design
Treatments tested in this trial
- Implant placement (BLX implant system, Straumann, Basel, Switzerland)
- Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)
- Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)