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Completed

NCT Number: NCT02736773

Xenograft and Posterior Mandibular Socket Filling

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.

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Key information

Conditions

Xenograft Model

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHMontpellier - AHU CSERD

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

xenograft material to slow resorption

Other

xenograft material to slow resorption (Bio-Oss®)

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

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

Acronym: Flapless

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2016
Registry last updated
Aug 5, 2019

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.

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