Xenograft and Posterior Mandibular Socket Filling

NCT02736773 | Completed

• 1 other identifier: 9631
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Xenograft Model

Keywords

Guided Bone; Pre-implant referred; Regeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cone beam pre implant examination

  5 or 6 months

• Clinical measures

  Day of surgery

Study Arms (1)

xenograft material to slow resorption

EXPERIMENTAL

xenograft material to slow resorption (Bio-Oss®)

Other: xenograft material to slow resorption

Interventions

xenograft material to slow resorption OTHER

xenograft material to slow resorption (Bio-Oss®)

xenograft material to slow resorption

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a unit or avulsion and ROG including 2 adjacent teeth maximum premolars
• aged 18 to 75
• Patients can meet the demands of implant treatment (attendance, hygiene)
• Patients showing no indication against-General to surgery

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UHMontpellier - AHU CSERD

Montpellier, 34295, France

Location

Study Officials

• Philippe BOUSQUET, MCU PH

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 13, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 5, 2019

Record last verified: 2019-07

Locations

FR (1)