NCT06432699

Brief Summary

DEFINITION: A short description of clinical study , including a brief statement of clinical study's hypothesis, written in language intended for the lay public Limit: 5000 CHARACTERS

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 27, 2025

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

May 23, 2024

Last Update Submit

January 23, 2025

Conditions

Keywords

MOP

Outcome Measures

Primary Outcomes (1)

  • pain will be measured after intervention of visual analogue scale

    patient after undergoing micro-osteoperforation will be aske to measure pain and check rate of canine retraction

    three months since the MOPS

Study Arms (2)

Control

NO INTERVENTION

Participants in this arm will receive no MOP treatment

Experimental

EXPERIMENTAL

participants in this arm will receive MOPS intervention

Other: micro osteoperforation

Interventions

one side used for mops while other side will be control in same patient

Also known as: Placebo/Controlled
Experimental

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 1. Age range around 15-40 years. 2. Patients which have class I malocclusion or class II Div I malocclusion and include first premolar extraction as part of treatment plan..
  • \. No orthodontic treatment previously 4. Radiographic evidence showing no bone loss 5. History showing no periodontal disease. 6. History showing no systemic disease. 7. Probing depth less than 4 mm across the entire dentition 8. No active carious lesion or any sign of gingivitus

You may not qualify if:

  • Presence of any craniofacial abnormality.
  • Any history of bleeding disorders.
  • Poor oral hygiene.
  • Use of bisphosphonates, analgesics, anti-inflammatory drugs, corticosteroids for more than three months prior to treatment or during treatment.
  • Active diseases such as metabolic bone disease.
  • Malocclusions requiring surgical intervention.
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Punjab Province, 04403, Pakistan

Location

Related Publications (1)

  • 1. Kundi, I., Alam, M. K., & Shaheed, S. (2020). Micro-osteo perforation effects as an intervention on canine retraction. The Saudi dental journal, 32(1), 15-20. https://doi.org/10.1016/j.sdentj.2019.05.009 2. Husain S, Sundari S. Comparison of the effectiveness of piezocision-aided canine retraction augmented with micro-osteoperforation: a randomized controlled trial. Angle Orthod. 2023 Oct 16. doi: 10.2319/052323-370.1. Epub ahead of print. PMID: 37839802. 12 3. Aboalnaga AA, Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split- mouth randomized controlled trial. Prog Orthod. 2019 Jun;20(1) 21. doi:10.1186/s40510-019-0274-0. PMID: 31155698; PMCID: PMC6545296. 4. Bolat Gümüş, E., Kınsız, E. Effects of miniscrew-facilitated micro- osteoperforations on the rate of orthodontic tooth movement. J Orofac Orthop 84 (Suppl 2), 104-110 (2023). 5. Martina K., Kumar P., Misra V., Attri S., Yadav A., Sam R., Kumar R.. To evaluate the rate of canine retraction and pain perception following micro- osteoperforation - a split-mouth clinical study. Australasian Orthodontic Journal. 2022;38(2): 388-395

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants will be randomly assigned to receive Micro-osteoperforation and the other side will be control.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either MOPS or no Mops
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ZAINAB BUTT

Study Record Dates

First Submitted

May 23, 2024

First Posted

May 29, 2024

Study Start

May 1, 2024

Primary Completion

July 30, 2024

Study Completion

December 30, 2024

Last Updated

January 27, 2025

Record last verified: 2024-06

Locations