Xenograft and Posterior Mandibular Socket Filling
- Conditions
- Xenograft Model
- Interventions
- Other: xenograft material to slow resorption
- Registration Number
- NCT02736773
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
The aim of this study is to evaluate the volume of madibular bone after placement of a xenograft in a fresh extraction socket in human. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 35 patients.
- Detailed Description
Primary objective :
Estimate the percentage of loss of bone volume and the percentage thickness loss of the buccal and palatal cortical for patients who underwent bone volume preservation technology and conservation of the vestibular cortical by guided bone regeneration using a material slow absorption in the molar areas and premolar.
Secondary objectives:
Compare the percentage of loss of bone volume and the percentage loss of thickness of the buccal and palatal cortical patients who underwent a preservation technique, the upgrading data of mandibular posterior region without fillers described in the literature.
Methods :
After tooth extraction of a premolar or molar in mandibular flapless technique, guided bone regeneration is carried out. The cell is filled by a slow absorption material (Xenograft common use). The regeneration space is maintained by a resorbable membrane. To protect the membrane without tissue motion (technical flapless) placing a three-dimensional collagen matrix graft substitute gingival (Muccograft®) will be used. A CBCT preoperative be performed to verify the integrity of cortical and measure the height and width of the residual cavity. caliper measurements at the foot will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.
After healing of the graft, the pre-implant scan performed at six months postoperatively will measure the height and width of the grafted cell, to compare measurements and evaluate the dynamics of alveolar resorption
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description xenograft material to slow resorption xenograft material to slow resorption xenograft material to slow resorption (Bio-Oss®)
- Primary Outcome Measures
Name Time Method Cone beam diagnostic examination Day diagnostic (Day 0) Cone beam diagnostic examination: Millimeter measurements will be taken at Day 0.
This examination is an X-ray technique that uses a cone-shaped radiation beam. The measurements will be made on radiographic examinations
Mucous measures
* Vestibular cortical Distance, lingual cortical measured in the middle of the cell
* Depth of the slot lingual cortical side
* Depth of the cell vestibular cortical side
Bone measures
* Thickness of the lingual cortical measured caliper 2 millimeters under the rim
* Vestibular cortical thickness measured with calipers 2 millimeters under the rim
* Depth of the slot lingual cortical side
* Depth of the cell vestibular cortical side
- Secondary Outcome Measures
Name Time Method Clinical measures Day of surgery Clinical measures on the day of surgery
Bone measures
* Thickness of the lingual cortical measured caliper 2 millimeters under the rim
* Vestibular cortical thickness measured with calipers 2 millimeters under the rim
* Cortical vestibular cortical lingual distance, measured in the middle of the cell
* Depth of the slot lingual cortical side
* Depth of the cell vestibular cortical side
Mucous measure:
* Gum buccal keratinized
* Keratinized gingiva lingual
* Cortical vestibular cortical lingual distance measured in the middle of the cellCone beam pre implant examination 5 or 6 months Cone beam pre implant examination : millimeter measurements will be taken at 5 or 6 months.
This examination is an X-ray technique that uses a cone-shaped radiation beam. The measurements will be made on radiographic examinations
Mucous measures
* Vestibular cortical Distance, lingual cortical measured in the middle of the cell
* Depth of the slot lingual cortical side
* Depth of the cell vestibular cortical side
Bone measures
* Thickness of the lingual cortical measured caliper 2 millimeters under the rim
* Vestibular cortical thickness measured with calipers 2 millimeters under the rim
* Depth of the slot lingual cortical side
* Depth of the cell vestibular cortical side
Trial Locations
- Locations (1)
UHMontpellier - AHU CSERD
🇫🇷Montpellier, France