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Xenograft and Posterior Mandibular Socket Filling (Flapless)

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ClinicalTrials.gov Identifier: NCT02736773
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Xenograft Model Other: xenograft material to slow resorption Not Applicable

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ridge Preservation With a Low Resorption Xenograft in Posterior Mandible Postextraction Sockets
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : September 1, 2018

Arm Intervention/treatment
Experimental: xenograft material to slow resorption
xenograft material to slow resorption (Bio-Oss®)
Other: xenograft material to slow resorption
xenograft material to slow resorption (Bio-Oss®)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736773


Locations
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France
UHMontpellier - AHU CSERD
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Philippe BOUSQUET, MCU PH University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02736773     History of Changes
Other Study ID Numbers: 9631
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC
Keywords provided by University Hospital, Montpellier:
Guided Bone
Pre-implant referred
Regeneration