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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04051905
Other study ID # RECHMPL19_0395
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date March 6, 2020

Study information

Verified date March 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 6, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France UHMontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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