The Evaluation Of The Efficiency Of Micro-osteoperforation

NCT03652454 | Completed Results FDA Device

• 1 other identifier: 2016TDRSABE0026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Crowding of Teeth

Keywords

regional acceleratory phenomenon; micro-osteoperforation; orthodontic alignment

Outcome Measures

Primary Outcomes (1)

• 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.

  From the initiation of the treatment to the completion of alignment stage (approximately 6 months)

Study Arms (2)

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.

Device: micro-osteoperforation; Other: conventional fixed appliance treatment

conventional treatment

OTHER

conventional fixed appliance treatment

Other: conventional fixed appliance treatment

Interventions

micro-osteoperforation DEVICE

Propel device (ABD) using for regional acceleratory phenomenon

micro-osteoperforation

conventional fixed appliance treatment OTHER

conventional fixed appliance treatment

conventional treatment; micro-osteoperforation

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

İzmirli, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37167078 DERIVED

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Results Point of Contact

• Title: dr.dt.mücahid faik şahin
• Organization: IzmirKCU

m.faiksahin@hotmail.com

+902323254040

Study Officials

• Aslı Baysal, PhD

  Izmir Katip Celebi University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: parallel assignment

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: August 29, 2018
• Study Start: October 3, 2017
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: October 3, 2022
• Results First Posted: January 25, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)