Patients Requiring Mandible Orthodontic TreatmentPhase 4NCT03655938
Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration
A Phase 4 study testing Piezocision combined minimally invasive alveolar bone regeneration in people with Patients Requiring Mandible Orthodontic Treatment, run by University of Liege at 1 site in Belgium.
Trial summary
This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Requiring Mandible Orthodontic Treatment
- What is being tested?
- Piezocision combined minimally invasive alveolar bone regeneration
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2017to 20 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring at least mandible orthodontic treatment (both arches)
- Patient presenting alveolar bone thickness < XX mm
- Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
- Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
- American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
- Adequate dento-oral health (i.e., the absence of periodontal diseases, peri-apical infection, or untreated caries).
Who cannot join
- Controlled periodontitis with a loss of alveolar support > 10%
- Gingival recession > 2 mm
- Smokers
- Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
- Mental or motor disabilities
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration : a Prospective Study
This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.
- Being tested
- Piezocision combined minimally invasive alveolar bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezocision combined minimally invasive alveolar bone regenerationProcedure or surgery
The piezocision surgery was performed two weeks after orthodontic appliance placement. The patients received local anesthesia in mandibular arch and vertical interproximal incisions were made below the interdental papillae in the midline, from the mesial aspect of each canine and in between each of the posterior lower teeth. The periostium was then released in order to create two subperiotal envelopes connecting the vertical incisions together. Thereafter, corticotomies were performed in the region of the incisions with a piezotome (Acteon, Merignac, France) and the envelopes were filled with a beta tricalcium phosphate, a resorbable biomaterial in order to thicken the buccal bone plate. Resorbable 5-0 sutures were used to close the flaps. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic change from Baseline and after 1year
The patients underwent baseline and post treatment CBCT scans (Somaton® Emotion; Siemens, Munich, Germany). Measurements of the alveolar bone changes in the lower front region on pre- and post- treatment CT volumes were done by reformatting the orthogonal slices, along the sagittal, coronal and axial length axes of each individual tooth. A strict vestibular bone level measurement (sagittal slice) and three alveolar bone width measurements at crestal level, 3mm from the crest and 6mm from the crest (axial slices) were performed per individual tooth. In addition, CT images were analyzed in using a dedicated platform in an image processing software (MeVisLab, MeVis Medical Solutions AG, Bremen,Germany) where pre- and post-treatment volumes were superposed using rigid image registration. Semi-automatically segmentation using region growing with same seed-point and threshold value for both scans, was followed with a hole-filling algorithm to obtain segmented volumes of the cropped image in
Measured: Baseline and after 1year
Secondary outcomes (2)
Periodontal Evaluation
The following clinical parameters were measured at baseline and after the orthodontic treatments: recession depths (RDs), pocket depth, plaque index (PI) and papilla bleeding index (PBI). A recession score was calculated by summing the recession depths. Next, the presence of gingival scars due to the overall treatment of each patient was categorized as an absence of scars, point-shape scars or linear-shape scars. Full periodontal charting (probing in four sites per tooth) was performed in all patients before and after the treatment; the results were expressed as score per sextant.
Measured: Baseline and after 1 year
Patient assessment
The patient-centered outcomes were recorded using a Visual Analog Scale questionnaire that employed a 0-10 graduated scale. The following parameters were collected: apprehension before treatment (scale ranges, minimum=0 and maximum=10) scores), pain level after treatment and daily analgesic consumption following orthodontic appliance placement and piezocision (scale ranges, minimum=0 and maximum=10). After the overall treatment, the levels of satisfaction in terms of the final result (scale ranges, minimum=0 and maximum=10), the treatment duration and whether the patient would recommend the procedure to a friend were assessed (scale ranges, Yes=0 and No=10). Finally, the patients were asked whether they would undergo the treatment again (scale ranges, Yes=0 and No=10).
Measured: Baseline and after 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start20 Mar 2017
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Requiring Mandible Orthodontic TreatmentStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655938
- Sponsor's protocol ID
- P2016-1 In-OP WP2
- Status last verified
- Aug 2018
- First submitted
- 11 Jun 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charavet C, Lecloux G, Vandenberghe B, Lambert F. Buccal bone regeneration combined with piezocision in adult orthodontic patients: Clinical, 3D radiographic, and patient-reported outcomes. J Stomatol Oral Maxillofac Surg. 2021 Dec;122(6):549-556. doi: 10.1016/j.jormas.2020.10.005. Epub 2020 Oct 22.
PubMed 33289660
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piezocision-assisted Orthodontic Treatment Combined With Alveolar Bone Regeneration : a Prospective Study
- ClinicalTrials.gov ID
- NCT03655938
- Acronym / sponsor ID
- P2016-1 In-OP WP2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 31 Aug 2018 (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.
This study was designed to enroll a series of 10 consecutive patients who met the inclusion criteria. Patients were treated in the Department of Orthodontics and Dento-Facial Orthodopedics of the University of Liège. Two senior's orthodontists and two senior's periodontists were involved in the orthodontic treatment and in the surgical procedures respectively. All clinical, radiographic and periodontal measurements and all orthodontic parameters were performed at baseline and after the orthodontic treatments. Tree examiners collected the overall data.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients requiring at least mandible orthodontic treatment (both arches)
- Patient presenting alveolar bone thickness < XX mm
- Adult patients with completed growth based on the Cervical Vertebral Maturation Method (CVM) as described by Baccetti et al. (Baccetti et al. 2002)
- Minimal to moderate mandibular anterior crowding at baseline (irregularity index≤6) (Little 1975)
- American Society of Anesthesiology I or II (I = Normal healthy patient; II = Patients with mild systemic disease)
Key exclusion criteria (6 listed)
- Controlled periodontitis with a loss of alveolar support > 10%
- Gingival recession > 2 mm
- Smokers
- Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
- Mental or motor disabilities
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 |
|---|---|---|
| Piezocision combined minimally invasive alveolar bone regenerationThe piezocision surgery was performed two weeks after orthodontic appliance placement. The patients received local anesthesia in mandibular arch and vertical interproximal incisions were made below the interdental papillae in the midline, from the mesial aspect of each canine and in between each of the posterior lower teeth. The periostium was then released in order to create two subperiotal envelopes connecting the vertical incisions together. Thereafter, corticotomies were performed in the region of the incisions with a piezotome (Acteon, Merignac, France) and the envelopes were filled with a beta tricalcium phosphate, a resorbable biomaterial in order to thicken the buccal bone plate. Resorbable 5-0 sutures were used to close the flaps. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days. | Procedure or surgery | – |
Primary outcome
Radiographic change from Baseline and after 1year
Time frame: Baseline and after 1year
The patients underwent baseline and post treatment CBCT scans (Somaton® Emotion; Siemens, Munich, Germany). Measurements of the alveolar bone changes in the lower front region on pre- and post- treatment CT volumes were done by reformatting the orthogonal slices, along the sagittal, coronal and axial length axes of each individual tooth. A strict vestibular bone level measurement (sagittal slice) and three alveolar bone width measurements at crestal level, 3mm from the crest and 6mm from the crest (axial slices) were performed per individual tooth. In addition, CT images were analyzed in using a dedicated platform in an image processing software (MeVisLab, MeVis Medical Solutions AG, Bremen,Germany) where pre- and post-treatment volumes were superposed using rigid image registration. Semi-automatically segmentation using region growing with same seed-point and threshold value for both scans, was followed with a hole-filling algorithm to obtain segmented volumes of the cropped image in
2 secondary outcomes
Periodontal Evaluation
Time frame: Baseline and after 1 year
Patient assessment
Time frame: Baseline and after 1year
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 31 Aug 2018.
- Derived from this study: PubMed 33289660Charavet C, Lecloux G, Vandenberghe B, Lambert F. Buccal bone regeneration combined with piezocision in adult orthodontic patients: Clinical, 3D radiographic, and patient-reported outcomes. J Stomatol Oral Maxillofac Surg. 2021 Dec;122(6):549-556. doi: 10.1016/j.jormas.2020.10.005. Epub 2020 Oct 22.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piezocision combined minimally invasive alveolar bone regeneration in people with Patients Requiring Mandible Orthodontic Treatment, run by University of Liege at 1 site in Belgium.
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 6 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 Belgium. 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.
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?
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?
Radiographic change from Baseline and after 1year (time frame: Baseline and after 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655938, which also lists 1 linked publication.
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 31 Aug 2018.