Ankylosed TeethOBSNCT02337153
Ankylosed Teeth Treatment by Bone Orthodontic Treatment
An observational study of Ankylosed Teeth, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Ankylosed Teeth
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2014to 31 Dec 2021
- 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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient in need of orthodontic treatment and presenting one or more teeth stiff
Who may be able to join
- Patient in need of orthodontic treatment and presenting one or more teeth stiff
- Can meet the requirement of orthodontic treatment (attendance, quality of brushing)
- Showing no indication against General Surgery
Who cannot join
- A patient against indication for orthodontic treatment : Root resorption of teeth adjacent to stiff teeth, Dental anchoring Deficiency by multiple agenesis or agenesis of the adjacent teeth to teeth stiff, Loss of periodontal support or active periodontal disease
- A patient against indication to treatment with Corticotomy : General Pathology against indicating surgery, Proximity root with no possibility of improvement orthodontic preparation
- Inability to maintain a good level of oral hygiene and good cooperation.
Trial locations and contacts
1 site in 1 country.
Matthieu RENAUD contact
France1 site, 1 recruiting
- Recruiting
UHMontpellier - AHU CSERD
Montpellier, 34295
Philippe BOUSQUET, philipbousquet@free.fr
Matthieu RENAUD, matt.renaud18@live.fr
About this study
Official title: Study of Validation of Measurements of the Movement of Stiff Treated Teeth and Orthodontic Corticotomy
Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement.
Read the detailed description
Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement.
During treatment the teeth by stiff Corticotomy, millimeter measurements are performed on a cohort of patients with this pathology. These measures take place during normal clinical phases and on all media such as, plaster models, photographs and radiological examinations performed at the beginning, during and at the end of treatment.
- Conditions
- Ankylosed Teeth
- Keywords
- Orthodontique Bone Stretching
- Medical subject headings
- Tooth Ankylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the distal view of the tooth mesial to the stiff corner of the adjacent tooth
Millimeter caliper measurements from the point of view of tooth distal to mesial stiff angle of the adjacent tooth during care for treatment corticotomy
Measured: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Secondary outcomes (4)
Change of the mesial angle of the ankylosed tooth to the distal (or mesial) angle of the adjacent tooth
Millimeter caliper measurements from the mesial angle of the ankylosed tooth to the distal (or mesial) angle of the adjacent tooth during care for treatment corticotomy
Measured: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of the incisal edge of ankylosed tooth to the Incisal edge of lower incisor, In occlusion
Millimeter caliper measurements of the incisal edge of the ankylosed tooth incisal edge of lower incisor in occlusion during care for treatment
Measured: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of free gingival margin of the ankylosed tooth to the gingival margin of the distal adjacent tooth
Millimeter caliper measurements from free gingival margin of the ankylosed tooth to the gingival margin of the distal adjacent tooth during care for treatment corticotomy
Measured: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of free gingival margin of the ankylosed tooth to the gingival margin of the mesial adjacent tooth
Millimeter caliper measurements from free gingival margin of the ankylosed tooth to the gingival margin of the mesial adjacent tooth during care for treatment corticotomy
Measured: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study start7 Apr 2014
- Primary completion1 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosed TeethStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Firm Orthodontics - Mauguio - French, Universitat Internacional de Catalunya
- Responsible party
- Sponsor
- Investigators
- Philippe BOUSQUET, MCU PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337153
- Sponsor's protocol ID
- 9367
- Acronym
- OBS
- Status last verified
- Aug 2019
- First submitted
- 31 Dec 2014
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Validation of Measurements of the Movement of Stiff Treated Teeth and Orthodontic Corticotomy
- ClinicalTrials.gov ID
- NCT02337153
- Acronym / sponsor ID
- OBS / 9367
- Conditions
- Ankylosed Teeth
- Keywords
- Orthodontique Bone Stretching
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Firm Orthodontics - Mauguio - French, Universitat Internacional de Catalunya
- Study start
- 7 Apr 2014 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Jan 2015 (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.
Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement.
Detailed description
Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement.
During treatment the teeth by stiff Corticotomy, millimeter measurements are performed on a cohort of patients with this pathology. These measures take place during normal clinical phases and on all media such as, plaster models, photographs and radiological examinations performed at the beginning, during and at the end of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient in need of orthodontic treatment and presenting one or more teeth stiff
Key inclusion criteria (3 listed)
- Patient in need of orthodontic treatment and presenting one or more teeth stiff
- Can meet the requirement of orthodontic treatment (attendance, quality of brushing)
- Showing no indication against General Surgery
Key exclusion criteria (3 listed)
- A patient against indication for orthodontic treatment : Root resorption of teeth adjacent to stiff teeth, Dental anchoring Deficiency by multiple agenesis or agenesis of the adjacent teeth to teeth stiff, Loss of periodontal support or active periodontal disease
- A patient against indication to treatment with Corticotomy : General Pathology against indicating surgery, Proximity root with no possibility of improvement orthodontic preparation
- 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
Change of the distal view of the tooth mesial to the stiff corner of the adjacent tooth
Time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Millimeter caliper measurements from the point of view of tooth distal to mesial stiff angle of the adjacent tooth during care for treatment corticotomy
4 secondary outcomes
Change of the mesial angle of the ankylosed tooth to the distal (or mesial) angle of the adjacent tooth
Time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of the incisal edge of ankylosed tooth to the Incisal edge of lower incisor, In occlusion
Time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of free gingival margin of the ankylosed tooth to the gingival margin of the distal adjacent tooth
Time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Change of free gingival margin of the ankylosed tooth to the gingival margin of the mesial adjacent tooth
Time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
Related trials for Ankylosed Teeth
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Risk Factors for Tooth Eruption Diseases
Tooth Eruption Disorder
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.
Matthieu RENAUD contact
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 Ankylosed Teeth, 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 3 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: status not confirmed, as of the sponsor's last update on 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe BOUSQUET, MCU PH (0613212053, philipbousquet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the distal view of the tooth mesial to the stiff corner of the adjacent tooth (time frame: Before orthodontic preparation, At the end of the orthodontic preparation on the day of surgery, Then 7 days, 15 days, 21 days, 30 days, 45 days, 60 days from the date of Surgery, at the end of the treatment of ankylosed teeth). 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 2 Aug 2019.