Bone Loss in Posterior Mandible Postextraction Sockets

Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique

The aim of this study is to evaluate the bone loss after extraction. 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 40 patients

Study Overview

• Status: Completed
• Conditions: Guided Bone

Detailed Description

Primary objective :

Estimate the percentage of bone volume loss o and the percentage thickness loss of the buccal and palatal cortical for patients who underwent natural healing in the mandibular molar and premolar areas.

Methods :

Before tooth extraction of a premolar or molar in mandibular area by flapless technique, a CBCT preoperative is performed to verify the integrity of cortical and measure the height and width of the residual cavity. Caliper measurements will also be performed during surgery in order to integrate also the thickness of the bone tables and gingival thickness.

After natural healing , 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: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Population of patients aged between 18 and 80 years with one to two posterior mandibular teeth to extract in absence of bone graft and able to benefit from a flapless technique.

Description

Inclusion criteria

• patients requiring tooth extraction
• aged 18 to 80
• Patients showing no indication against-General to surgery

Exclusion criteria

• Patient with against-indication for surgical treatment.
• Patients with an important loss of vestibular cortical
• Patients requiring and accepting a bone graft
• Unstabilized periodontal disease or aesthetic indication.
• 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

• Observational Models: Cohort
• Time Perspectives: Prospective

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): September 30, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Regeneration
• Other Study ID Numbers: RECHMPL19_0395

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No