Evaluation of the Effect of Micro-osteoperforation on the Rate of Bone Anchored Molar Distalization

NCT06497244 | Recruiting

• 1 other identifier: MOPD-CU-2022-11-15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the current study was to evaluate three dimensionally, using digital models and cone beam computed tomography imaging, the effect of micro-osteoperforations on the rate of tooth movement in the first molar distalization.

Conditions

Microosteoperforations

Outcome Measures

Primary Outcomes (2)

• rate of molar distalization

  Incremental rate of molar distalization every month by intra oral scan superimposition

  6 months

• total molar distalization distance by mm between T6 and T0

  Total distance moved by the molar after 6 months by intra oral scan superimposition and measure the linear difference in position 1st molar between T6 and T0 by mm

  6 months

Secondary Outcomes (5)

• The effect of MOPs on Maxillary 1st molar tipping by degrees between T6 and T0

  6 months

• The effect of MOPs on Maxillary 1st molar rotation by degrees between T6 and T0

  6 months

• The effect of MOPs on Maxillary 1st molar vertical movement by mm between T6 and T0

  6 months

• The effect of MOPs on 1st molar root resorption level by mm between T6 and T0

  6 months

• Detecting any Pain or discomfort caused by the micro-osteoperforations using Numeric pain rating scale

  1 week

Study Arms (2)

micro osteo-perforation side

EXPERIMENTAL

the patient will receive micro osteo-perforation in one side Computer generated random numbers will generated using Microsoft Office Excel sheet by a person who was not involved in the clinical trial. Because of the split mouth design, the right sides of patients will randomly be assigned to one of the two groups (MOPs or control). Then, the left sides will automatically be assigned to the alternative group.

Procedure: micro osteo-perforation

no micro osteo-perforation side

NO INTERVENTION

the other side without micro osteo-perforation

Interventions

micro osteo-perforation PROCEDURE

the patient will receive miniscrew micro osteo-perforation in one side every month with molar distalization and the other side the distalization without micro osteo-perforation

micro osteo-perforation side

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Skeletal Class I or mild Class II relationship
• Dental class II bilaterally (non-extraction cases)
• Full permanent dentition including 2nd maxillary molars
• Good oral hygiene
• Medically free

You may not qualify if:

• Systemic diseases that may interfere with the treatment
• Use of any medications that might have affected the biology of tooth movement
• unilateral Class II molar relationship
• extreme skeletal Class II relationship (ANB \>7°)
• periodontal disease or alveolar bone loss
• Patients with dental anomalies in maxillary 1st molar

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

Study Officials

• Fatma Abdou, professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohamed Elsayed, PhD

CONTACT

00201064111810; mohamedessam4@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The first assessor will perform the digital models \& CBCT measurements blindly for each patient. The second assessor will perform the same measurements blindly to calculate the inter-observer error
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will receive MOPs randomly to either the left or right maxillary molar buccal alveolar regions. MOPs will be performed at the first day of the distalization treatment (T0) and will repeated every 2 months.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 11, 2024
• Study Start: September 10, 2023
• Primary Completion: October 10, 2024
• Study Completion: December 30, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)