Class I MalocclusionPhase 4NCT02866929
A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics
A Phase 4 study testing Decortication, Orthodontics and Mucograft in people with Class I Malocclusion and Other Periodontal Diseases, run by CES University.
Trial summary
Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Malocclusion, Other Periodontal Diseases, Thin Gingival Biotype
- What is being tested?
- Decortication, Orthodontics and Mucograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2018
- Phase
- Phase 4
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Angle's class I malocclusion
- Little's grade II or III dental crowding
- Periodontally stable patients
- Patients with no more than 2 mm of keratinized gingiva in at least two sites of the antero-inferior region
Who cannot join
- Patient with presence of marginal tissue recessions on inferior incisors
- Patients with a metabolic or neoplastic alteration
- History of orthopedic surgery in the last 6 months
- History of fractures in the last 6 months
- History of bisphosphonates use
- Patient with systemic compromise
About this study
Official title: Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication
Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Therefore, case selection and the implementation of periodontal biotype enhancing strategies become a relevant consideration to ensure long-term successful treatment outcomes. This study focuses on the biological and clinical value of the use of a porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect that supports an increase on tooth movement rate. The designs of this randomized controlled clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements will capture the clinical phenotype; while the biologic phenotype will be derived from evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and Interleukin-1RA. The significance and innovative value of this proposal stems from the use of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the corticotomy. This approach could prove to be effective to further increase the therapeutic window that allows accelerating orthodontic treatment and, at the same time, could decrease the recession risk in movements of proclination of antero-inferior incisors. Besides, the use of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory outcome that could be evaluated as an alternative to decortication.
- Being tested
- Decortication, Orthodontics, Mucograft
- Keywords
- orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic Treatment
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecorticationProcedure or surgery
Under local anesthesia, vertical and inter-radicular gingival incisions will be performed on the vestibular of the maxillary and mandibular arch, starting 2-3 mm below the interdental papilla and with sufficient depth to the periosteum to allow the scalpel to reach the alveolar bone. These incisions will be kept as small as possible; then, through them, using a piezoelectric scalpel (piezotome), several bone cuts will be performed. These cuts will have sufficient depth for drilling the cortical alveoli.
OrthodonticsDevice
Self-ligation brackets in upper and lower teeth
MucograftDrug
Porcine naturally cross-linked collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| Conventional orthodontic treatment | Active comparator | Patients that will receive conventional orthodontics Receives: Device: Orthodontics |
| Orthodontics with decortication | Experimental | Patients that will receive orthodontic treatment with selective alveolar decortication Receives: Procedure: Decortication; Device: Orthodontics |
| Orthodontics decortication and Mucograft | Experimental | Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment Receives: Procedure: Decortication; Device: Orthodontics; Drug: Mucograft |
| Orthodontics and Mucograft® | Experimental | Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment Receives: Device: Orthodontics; Drug: Mucograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.
Measured: 2 years
Secondary outcomes (3)
Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
Measured: 4 weeks
Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures.
Measured: 2 years
Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I MalocclusionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Universidad del Valle, Colombia
- Responsible party
- Principal investigator, Maria Antonia Alvarez, CES University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866929
- Sponsor's protocol ID
- ODCES001
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2016
- Last updated
- 20 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication
- ClinicalTrials.gov ID
- NCT02866929
- Acronym / sponsor ID
- ODCES001
- Keywords
- orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Universidad del Valle, Colombia
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 15 Aug 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.
Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Therefore, case selection and the implementation of periodontal biotype enhancing strategies become a relevant consideration to ensure long-term successful treatment outcomes. This study focuses on the biological and clinical value of the use of a porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect that supports an increase on tooth movement rate. The designs of this randomized controlled clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements will capture the clinical phenotype; while the biologic phenotype will be derived from evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and Interleukin-1RA. The significance and innovative value of this proposal stems from the use of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the corticotomy. This approach could prove to be effective to further increase the therapeutic window that allows accelerating orthodontic treatment and, at the same time, could decrease the recession risk in movements of proclination of antero-inferior incisors. Besides, the use of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory outcome that could be evaluated as an alternative to decortication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conventional orthodontic treatment | Active comparator | Device: OrthodonticsPatients that will receive conventional orthodontics |
| Orthodontics with decortication | Experimental | Procedure: Decortication, Device: OrthodonticsPatients that will receive orthodontic treatment with selective alveolar decortication |
| Orthodontics decortication and Mucograft | Experimental | Procedure: Decortication, Device: Orthodontics, Drug: MucograftOrthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment |
| Orthodontics and Mucograft® | Experimental | Device: Orthodontics, Drug: MucograftPatients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Angle's class I malocclusion
- Little's grade II or III dental crowding
- Periodontally stable patients
- Patients with no more than 2 mm of keratinized gingiva in at least two sites of the antero-inferior region
Key exclusion criteria (6 listed)
- Patient with presence of marginal tissue recessions on inferior incisors
- Patients with a metabolic or neoplastic alteration
- History of orthopedic surgery in the last 6 months
- History of fractures in the last 6 months
- History of bisphosphonates use
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 |
|---|---|---|
| DecorticationUnder local anesthesia, vertical and inter-radicular gingival incisions will be performed on the vestibular of the maxillary and mandibular arch, starting 2-3 mm below the interdental papilla and with sufficient depth to the periosteum to allow the scalpel to reach the alveolar bone. These incisions will be kept as small as possible; then, through them, using a piezoelectric scalpel (piezotome), several bone cuts will be performed. These cuts will have sufficient depth for drilling the cortical alveoli. | Procedure or surgery | Orthodontics decortication and Mucograft, Orthodontics with decortication |
| OrthodonticsSelf-ligation brackets in upper and lower teeth | Device | Conventional orthodontic treatment, Orthodontics and Mucograft®, Orthodontics decortication and Mucograft, Orthodontics with decortication |
| MucograftPorcine naturally cross-linked collagen matrix | Drug | Orthodontics and Mucograft®, Orthodontics decortication and Mucograft |
Primary outcome
Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.
Time frame: 2 years
3 secondary outcomes
Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
Time frame: 4 weeks
Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures.
Time frame: 2 years
Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Decortication, Orthodontics and Mucograft in people with Class I Malocclusion and Other Periodontal Diseases, run by CES University.
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 4 inclusion and 6 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models. (time frame: 2 years). 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 20 Jul 2018.