Xenograft ModelFlaplessNCT02736773
Xenograft and Posterior Mandibular Socket Filling
A study testing xenograft material to slow resorption in people with Xenograft Model, run by University Hospital, Montpellier at 1 site in France.
Trial 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% . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xenograft Model
- What is being tested?
- xenograft material to slow resorption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2015to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Inability to maintain a good level of oral hygiene and good cooperation.
- Higher tobacco consumption has 10cig / day
- Acute dental infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ridge Preservation With a Low Resorption Xenograft in Posterior Mandible Postextraction Sockets
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.
Read the 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
- Conditions
- Xenograft Model
- Being tested
- xenograft material to slow resorption
- Keywords
- Guided Bone, Pre-implant referred, Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xenograft material to slow resorptionOther
xenograft material to slow resorption (Bio-Oss®)
| Study group | Role | What they receive |
|---|---|---|
| xenograft material to slow resorption | Experimental | xenograft material to slow resorption (Bio-Oss®) Receives: Other: xenograft material to slow resorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day diagnostic (Day 0)
Secondary outcomes (2)
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
Measured: 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
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xenograft ModelStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe BOUSQUET, MCU PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736773
- Sponsor's protocol ID
- 9631
- Acronym
- Flapless
- Status last verified
- Jul 2019
- First submitted
- 24 Feb 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation With a Low Resorption Xenograft in Posterior Mandible Postextraction Sockets
- ClinicalTrials.gov ID
- NCT02736773
- Acronym / sponsor ID
- Flapless / 9631
- Conditions
- Xenograft Model
- Keywords
- Guided Bone, Pre-implant referred, Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| xenograft material to slow resorption | Experimental | Other: xenograft material to slow resorptionxenograft material to slow resorption (Bio-Oss®) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
- Inability to maintain a good level of oral hygiene and good cooperation.
- Higher tobacco consumption has 10cig / day
- Acute dental infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xenograft material to slow resorptionxenograft material to slow resorption (Bio-Oss®) | Other | xenograft material to slow resorption |
Primary outcome
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
2 secondary outcomes
Cone beam pre implant examination
Time frame: 5 or 6 months
Clinical measures
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Xenograft Model
RecruitingObservational study
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe BOUSQUET, MCU PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xenograft material to slow resorption in people with Xenograft Model, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cone beam diagnostic examination (time frame: Day diagnostic (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.