Crowding of TeethNCT03652454
The Evaluation Of The Efficiency Of Micro-osteoperforation
A study testing micro-osteoperforation and conventional fixed appliance treatment in people with Crowding of Teeth, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Crowding of Teeth
- What is being tested?
- micro-osteoperforation and conventional fixed appliance treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2017to 24 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Existence of all permanent teeth (except molars 2 and 3)
- Subjects aged 30 and below
- Confusion of less than 8 mm according to model analysis of the upper and lower sieves
- Gingival and periodontal indices of less than 1
- Good oral hygiene
Who cannot join
- Congenitally missing tooth
- Severe skeletal malocclusion
- Systemic disease affecting tooth movement
- Active periodontal disease
- Smoking
- Radiographically detected bone loss
- Gingival pocket depth greater than 4 mm
- Previous surgical periodontal or orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency Of Micro-osteoperforation During Alignment Stage
Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage.
Twenty eight patients with mandibular arch discrepancy will be included in this research. After the patients are informed about the study they will be requested to sign the consent form.. At the beginning of the treatment routine orthodontic records (photographs, dental models and radiographs) will be taken and the gingival pocket measurements will be made.
The twenty eight patients will be randomly divided in two groups. In the first group, 3 or 4 micro-osteoperforations will be made in the parts of the gingiva nearby the discrepancy by perforating the keratinized or non-keratinized mucosa and reaching the alveolar bone under local anesthesia. In the further appointments the traditional aligning procedures will be used and controls will be made every 7-9 days. In the other group 20 patients will be treated in the traditional way and controls will be made each month. Every patient will be requested to answer questions related to treatment comfort and other problems like pain within the first week after each activations. The records will be repeated after the leveling phase. Tooth movement rate will be calculated according to the measurements made on dental casts. Measurements related to cephalometrics and gingival thickness will be evaluated. The results of two groups will be compared in terms of tooth movement rate, gingival thickness, pain and patient comfort.
Read the detailed description
Twenty eight patients who have crowding in mandibular arch will be included in the study.
At the beginning of the study, routine orthodontic records and gingival measurements will be taken.All the records will be repeated after alignment stage.
Clinical periodontal parameters including plaque index, gingival index, pocket depth and bleeding were measured with Williams periodontal scaler (Hu Friedy®, Chicago, IL, USA).
Gingival thickness will be recorded with a ultrasonic device (Pirop® Ultrasonic Biometer A- Scan, Echo-Son, Krancowa, Poland) Irregularity index will be calculated for each patient using dental casts. After bracket placement; twenty eight patients will be randomly allocated to treatment and control groups (fourteen patients in each group) While micro-osteoperforations will be applied to treatment group, the control group will receive no additional treatment.
Each patient will be asked to fulfill a questionnaire to evaluate patient satisfaction and ease of operation.
The data was analyzed statistically and the level of statistical significance was determined as p ≤ .05.
- Conditions
- Crowding of Teeth
- Being tested
- micro-osteoperforation, conventional fixed appliance treatment
- Keywords
- regional acceleratory phenomenon, micro-osteoperforation, orthodontic alignment
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforationDevice
Propel device (ABD) using for regional acceleratory phenomenon
conventional fixed appliance treatmentOther
conventional fixed appliance treatment
| Study group | Role | What they receive |
|---|---|---|
| micro-osteoperforation | Experimental | Propel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth. Receives: Device: micro-osteoperforation; Other: conventional fixed appliance treatment |
| conventional treatment | Other | conventional fixed appliance treatment Receives: Other: conventional fixed appliance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Mandibular Teeth Alignment
tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.
Measured: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start3 Oct 2017
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crowding of TeethStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Baysal, Izmir Katip Celebi University
- Investigators
- Aslı Baysal, PhD, Study director, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652454
- Sponsor's protocol ID
- 2016TDRSABE0026
- Status last verified
- Sep 2022
- First submitted
- 18 Oct 2017
- Last updated
- 3 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Faik Sahin M, Baysal A. The effect of micro-osteoperforation on the rate of tooth movement during the alignment stage in patients with mandibular crowding: a randomised controlled trial. Eur J Orthod. 2023 Sep 18;45(5):505-516. doi: 10.1093/ejo/cjad017.
PubMed 37167078
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Of Micro-osteoperforation During Alignment Stage
- ClinicalTrials.gov ID
- NCT03652454
- Acronym / sponsor ID
- 2016TDRSABE0026
- Conditions
- Crowding of Teeth
- Keywords
- regional acceleratory phenomenon, micro-osteoperforation, orthodontic alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 25 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged orthodontic treatment increases the risc of caries, periodontal problems and root resorption. Many different techniques were developed to shorten the treatment time. The aim of this study was to evaluate the effectiveness of micro-osteoperforations (MOP) performed in the alignment stage.
Twenty eight patients with mandibular arch discrepancy will be included in this research. After the patients are informed about the study they will be requested to sign the consent form.. At the beginning of the treatment routine orthodontic records (photographs, dental models and radiographs) will be taken and the gingival pocket measurements will be made.
The twenty eight patients will be randomly divided in two groups. In the first group, 3 or 4 micro-osteoperforations will be made in the parts of the gingiva nearby the discrepancy by perforating the keratinized or non-keratinized mucosa and reaching the alveolar bone under local anesthesia. In the further appointments the traditional aligning procedures will be used and controls will be made every 7-9 days. In the other group 20 patients will be treated in the traditional way and controls will be made each month. Every patient will be requested to answer questions related to treatment comfort and other problems like pain within the first week after each activations. The records will be repeated after the leveling phase. Tooth movement rate will be calculated according to the measurements made on dental casts. Measurements related to cephalometrics and gingival thickness will be evaluated. The results of two groups will be compared in terms of tooth movement rate, gingival thickness, pain and patient comfort.
Detailed description
Twenty eight patients who have crowding in mandibular arch will be included in the study.
At the beginning of the study, routine orthodontic records and gingival measurements will be taken.All the records will be repeated after alignment stage.
Clinical periodontal parameters including plaque index, gingival index, pocket depth and bleeding were measured with Williams periodontal scaler (Hu Friedy®, Chicago, IL, USA).
Gingival thickness will be recorded with a ultrasonic device (Pirop® Ultrasonic Biometer A- Scan, Echo-Son, Krancowa, Poland) Irregularity index will be calculated for each patient using dental casts. After bracket placement; twenty eight patients will be randomly allocated to treatment and control groups (fourteen patients in each group) While micro-osteoperforations will be applied to treatment group, the control group will receive no additional treatment.
Each patient will be asked to fulfill a questionnaire to evaluate patient satisfaction and ease of operation.
The data was analyzed statistically and the level of statistical significance was determined as p ≤ .05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| micro-osteoperforation | Experimental | Device: micro-osteoperforation, Other: conventional fixed appliance treatmentPropel device (ABD) Micro-osteoperforations were performed in the keratinized tissue. Micro-osteoperforations were 1.5 mm in diameter and 3-7 mm in depth. |
| conventional treatment | Other | Other: conventional fixed appliance treatmentconventional fixed appliance treatment |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Existence of all permanent teeth (except molars 2 and 3)
- Subjects aged 30 and below
- Confusion of less than 8 mm according to model analysis of the upper and lower sieves
- Gingival and periodontal indices of less than 1
- Good oral hygiene
Key exclusion criteria (8 listed)
- Congenitally missing tooth
- Severe skeletal malocclusion
- Systemic disease affecting tooth movement
- Active periodontal disease
- Smoking
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 |
|---|---|---|
| micro-osteoperforationPropel device (ABD) using for regional acceleratory phenomenon | Device | micro-osteoperforation |
| conventional fixed appliance treatmentconventional fixed appliance treatment | Other | conventional treatment, micro-osteoperforation |
Primary outcome
Rate of Mandibular Teeth Alignment
Time frame: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)
tooth movement rate (mm/month) was calculated. From the initiation of the treatment to the completion of alignment stage (approximately 6 months). All tooth movement rate measurements were performed in each month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37167078Faik Sahin M, Baysal A. The effect of micro-osteoperforation on the rate of tooth movement during the alignment stage in patients with mandibular crowding: a randomised controlled trial. Eur J Orthod. 2023 Sep 18;45(5):505-516. doi: 10.1093/ejo/cjad017.
- Individual participant dataSharing planned: No
Related trials for Crowding of Teeth
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
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.
Aslı Baysal, PhD study director
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforation and conventional fixed appliance treatment in people with Crowding of Teeth, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 8 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 3 Oct 2022. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Mandibular Teeth Alignment (time frame: From the initiation of the treatment to the completion of alignment stage (approximately 6 months)). 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 NCT03652454, 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 3 Oct 2022.