Xenograft and Posterior Mandibular Socket Filling (Flapless)

Ridge Preservation With a Low Resorption Xenograft in Posterior Mandible Postextraction Sockets

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.

Study Overview

• Status: Completed
• Conditions: Xenograft Model
• Intervention / Treatment: Other: xenograft material to slow resorption

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier - AHU CSERD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria general

• with a unit or avulsion and ROG including 2 adjacent teeth maximum premolars
• aged 18 to 75
• has given its no objection to participate in research Inclusion criteria patient
• Patients can meet the demands of implant treatment (attendance, hygiene)
• Patients showing no indication against-General to surgery

Exclusion criteria patient

• Patient with against-indication for implant treatment. Whether for medical reasons against showing the pre and implant surgery, or local reasons a total loss of vestibular cortical unstabilized periodontal disease or aesthetic cons-indication.

Exclusion criteria general

• Inability to maintain a good level of oral hygiene and good cooperation.
• Higher tobacco consumption has 10cig / day
• Acute dental infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: xenograft material to slow resorption; xenograft material to slow resorption (Bio-Oss®)	Other: xenograft material to slow resorption; xenograft material to slow resorption (Bio-Oss®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cone beam diagnostic examination	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	Day diagnostic (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cone beam pre implant examination	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	5 or 6 months
Clinical measures	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 cell	Day of surgery

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe BOUSQUET, MCU PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Regeneration; Guided Bone; Pre-implant referred
• Other Study ID Numbers: 9631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC