Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft
Not Applicable
Active, not recruiting
- Conditions
- Cleft Lip and Palate
- Registration Number
- NCT05971914
- Lead Sponsor
- Semmelweis University
- Brief Summary
The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- children with alveolar cleft
- patient presented at least three deciduous teeth scheduled for extraction.
Exclusion Criteria
- major relevant clinical diseases,
- systemic use of steroids,
- current or previous intravenous bisphosphonate treatment,
- acute infection at the operation site.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Radiological volumetric measurements 6 months Volumetric measurements will be conducted after the healing period. On prealigned pre- and postoperative CBCT cross-sections, linear measurements and volumetric measurements will be taken parallel to a reference base to determine the width of the surgical area.
- Secondary Outcome Measures
Name Time Method complications 1, 14, 30 days and 3 and 6 months after surgeries. Every complication will be reported
soft tissue healing during the 6 months postoperatively Healing of soft tissues was recorded via photo documentation.
Trial Locations
- Locations (1)
Semmelweis University Department of Periodontology
🇭🇺Budapest, Hungary
Semmelweis University Department of Periodontology🇭🇺Budapest, Hungary