Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05167708
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 31
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

Condition or Disease	Intervention/Treatment	Phase
Accretions; Teeth	Procedure: Micro-osteoperforation	N/A

Detailed Description

in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.
• Masking: Single (Outcomes Assessor)
• Masking Description: single blinded, the assessor of the out comes did not participate in the study
• Primary Purpose: Treatment
• Official Title: The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control the group underwent distalization, with no Micro-osteoperforation
Experimental: Single MOP the group underwent one time Micro-osteoperforation procedure	Procedure: Micro-osteoperforation; flapless small punctures in the bone at direction of tooth movement to accelerate the movement.
Experimental: repeated MOP the group underwent monthly Micro-osteoperforation procedure	Procedure: Micro-osteoperforation; flapless small punctures in the bone at direction of tooth movement to accelerate the movement.

Outcome Measures

Primary Outcome Measures

1. rate of maxillary first molar distal movement [through study completion, an average 1 year]

   evaluation of the whole rate of distal movement of the first molar

Secondary Outcome Measures

1. decrease in length of maxillary first molars in mm. [through study completion, an average 1 year]

   the change in the lengths of roots of maxillary first molars in mm.

2. bone density [through study completion, an average 1 year]

   bone density around the first molar

3. pain perception questionnaire [through study completion, an average 1 year]

   evaluate the pain perception to the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 20 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Space deficiency in the upper arch > 5 mm, and < 8 mm.

• Non-extraction lower arch.

• Full upper dentition up to the second molars.

• Third molar present in both sides, not yet erupted.

Exclusion Criteria:

• Systemic disease or syndrome.

• Evidence of root resorption.

• Poor oral hygiene.

• Previous orthodontic treatment

• Evidence of bone loss.

• Active periodontal disease.

• Pregnant females.

• Presence of oral habits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

• Study Chair: yasser lotfy, professor, Mansoura University
• Study Director: marwaa shamaa, ph.D, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa alkasaby, principal investigator, Mansoura University
• ClinicalTrials.gov Identifier: NCT05167708
• Other Study ID Numbers: A03120219
• First Posted: Dec 22, 2021
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Deposits

Study Results

No Results Posted as of Dec 22, 2021