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Completed

NCT Number: NCT04051905

Bone Loss in Posterior Mandible Postextraction Sockets

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

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Key information

Conditions

Guided Bone

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UHMontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cone beam diagnostic examination

    Time frame: 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 outcomes

  1. Cone beam pre implant examination

    Time frame: 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

  2. Clinical measures

    Time frame: 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 cell

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.