Guided BoneNCT04051905
Bone Loss in Posterior Mandible Postextraction Sockets
An observational study of Guided Bone, run by University Hospital, Montpellier at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Guided Bone
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2019to 6 Mar 2020
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of patients aged between 18 and 80 years with one to two posterior mandibular teeth to extract in absence of bone graft and able to benefit from a flapless technique.
Who may be able to join
- patients requiring tooth extraction
- aged 18 to 80
- Patients showing no indication against-General to surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique
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
Read the detailed 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.
- Conditions
- Guided Bone
- Keywords
- Regeneration
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 posted9 Aug 2019
- Study start30 Sep 2019
- Primary completion30 Dec 2019
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided BoneStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT04051905
- Sponsor's protocol ID
- RECHMPL19_0395
- Status last verified
- Mar 2020
- First submitted
- 8 Aug 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique
- ClinicalTrials.gov ID
- NCT04051905
- Acronym / sponsor ID
- RECHMPL19_0395
- Conditions
- Guided Bone
- Keywords
- Regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- 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 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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of patients aged between 18 and 80 years with one to two posterior mandibular teeth to extract in absence of bone graft and able to benefit from a flapless technique.
Key inclusion criteria (3 listed)
- patients requiring tooth extraction
- aged 18 to 80
- Patients showing no indication against-General to surgery
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Guided Bone
RecruitingPhase 1
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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?
An observational study of Guided Bone, 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 3 inclusion and 7 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 10 Mar 2020. 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 10 Mar 2020.