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Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Secondary endpoints: details revised at 1 of 12 entries
    • Study description shortened, about 1,894 words
    • Site details revised
    • Eligibility criteria shortened, about 4 words
    • Study title shortened, about 3 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06820489
Lead Sponsor University Ghent
Conditions
(from sponsor)
Bone Resorption
Related terms Bone Resorption
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov