Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement
A Three-arm Randomized Controlled Trial Comparing Transmucosal Augmentation Techniques in Immediate Implant Placement
University Ghent
54 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria6
- Pregnancy
- Systemic diseases
- Smoking; suppuration
- \> 1 mm gingival asymmetry between the failing and contralateral tooth
- Untreated periodontal disease
- Untreated caries lesions.
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Interventions
A pouch is made in the buccal mucosa extending 3 mm below the buccal bone crest. Thereupon, a free gingival graft is harvested from the palatal mucosa and de-epithelialized. The CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
No pouch is made in the recipient site. A free gingival graft is harvested from the palatal mucosa and de-epithelialized. The small CTG is fixed at the transmucosal aspect onto the buccal mucosa. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Sutures are removed 1 week after the surgery.
DBBM is applied and condensed up to the level of the buccal soft tissue margin. A healing abutment is installed, which is replaced by a provisional implant crown 2 days later. Usually, sutures are not needed in this group, unless minimal papilla opening was required to extract the tooth. In that case, sutures will be removed after 1 week.
Locations(1)
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NCT06820489