Effect of Gradually Increasing Force Magnitude on the Rate of Canine Retraction Randomized Controlled Trial

NCT05643443 | Unknown

• 1 other identifier: ORTH 3-3-3-3
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Therefore the aim of the current randomized controlled clinical trial is to investigate the effect of gradually increasing force magnitude versus constant force magnitude on the rate of tooth movement in a canine retraction model, furthermore investigate the effect of the two force systems on the ratio of cytokines and the pain experienced by the patient. Research question: In adult orthodontic patients requiring bilateral maxillary canines retraction, will gradually increasing force magnitudes accelerate the rate of canine retraction in the experimental side when compared to the control side?

Conditions

Canine Retraction

Outcome Measures

Primary Outcomes (2)

• Rate of canine retraction

  mm/time

  4 months

• change on the Cytokine levels in the gingival crevicular fluid

  ratio

  3 months

Secondary Outcomes (1)

• The effect of gradually increasing force magnitude on Pain

  4 months

Study Arms (2)

Control Group

NO INTERVENTION

Control Group

Active Group

EXPERIMENTAL

Active Group

Other: Gradual increase of force

Interventions

Gradual increase of force OTHER

steady force

Also known as: 150 gm

Active Group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and Females with an age ranging between 16-30 years (Adult patients since cooperation increases with age) (17).
• Malocclusion that requires extraction of the maxillary first premolars and canines retraction with moderate anchorage.
• Full permanent dentition with exception of the third molars.
• Good oral hygiene and periodontal condition (Probing depth\< 4 mm in all teeth), since the periodontal condition affects the amount and type of tooth movement.
• Absence of untreated caries which may worsen during the study time.

You may not qualify if:

• Medically compromised patients.
• Patients suffering from any congenital or hereditary diseases.
• Smoking or any systemic diseases.
• Chronic use of any medications including antibiotics, phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers. All the above factors affect the rate of tooth movement

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

Study Officials

• Mona Salah Fayed, Professor

  Cairo University, Faculty of Dentistry

  STUDY CHAIR

Central Study Contacts

Shady Abd ElSalam, PhD

CONTACT

00201008815748; dr.shadyabdelsalam@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)