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Status unknownNCT05643443Updated Dec 8, 2022

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

An interventional study of Gradual increase of force in Canine Retraction, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 16 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Cairo University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
16 Years to 30 Years
Sex
All
01

Study 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?

Read the detailed description

A. -Patient preparation:

  1. After patient selection, routine orthodontic records will be collected (study models, panoramic, lateral cephalometric radiographs, and intra-oral and extra-oral photographs).
  2. The orthodontic treatment: All subjects will receive a Straight Wire Appliance (SWA); Roth prescription slot 0.022 × 0.028 inch. The brackets will be bonded to the tooth surface using orthodontic light cured composite resin. Ready-made molar bands with 2 buccal tubes (main and auxiliary)1 will be selected, fitted, and cemented on the upper first molars using glass ionomer cement. The arch wire sequence in the initial levelling and alignment stage will be tailored according to the severity of crowding of each case.
  3. Just before canine retraction, alginate impressions will be made for the maxillary arch, CGF sample will be taken as described later in the same section, stainless steel arch wire 0.017 x 0.025 mil will be inserted.

B. Canine Retraction:

  1. The active group (gradually increasing force magnitude) will be randomly assigned to either the patients' left or right sides only (split mouth design).
  2. At the start of canine retraction, Nickel-titanium closed-coil springs applying 50 g and 150 g measured using Correx tension gauge will be used in the active side and control sides respectively on each side, stretched bilaterally from the hook on the first molar band to the hook of canine brackets(19).
  3. Activation will be done every 4 weeks.
  4. The impressions will be poured with dental stone within 15 minutes to ensure its accuracy.
  5. Visual analogue scale (VAS) will be explained to the patient and used to measure pain intensity in the postoperative period: immediately after the commencement of canine retraction and at each visit. The patient is asked to make three pain ratings each time to take an average. (one day, second day and one week after)
02

Conditions studied

  • Canine Retraction
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and Females with an age ranging between 16-30 years (Adult patients since cooperation increases with age) (17).
  2. Malocclusion that requires extraction of the maxillary first premolars and canines retraction with moderate anchorage.
  3. Full permanent dentition with exception of the third molars.
  4. 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.
  5. Absence of untreated caries which may worsen during the study time.

Exclusion criteria

Exclusion Criteria:

  1. Medically compromised patients.
  2. Patients suffering from any congenital or hereditary diseases.
  3. Smoking or any systemic diseases.
  4. 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
17 participants (estimated)

Study arms

  • No intervention
    Control Group

    Control Group

  • Experimental
    Active Group

    Active Group

    Other: Gradual increase of force

Interventions

  • OtherGradual increase of force

    steady force

    Also known as: 150 gm

06

What researchers measure

Primary outcomes

  1. Rate of canine retraction

    mm/time

    Time frame: 4 months

  2. change on the Cytokine levels in the gingival crevicular fluid

    ratio

    Time frame: 3 months

Secondary outcomes

  1. The effect of gradually increasing force magnitude on Pain

    numeric Pain scale ( 0 as no Pain - 10 As maximum Pain)

    Time frame: 4 months

07

Study locations

1 site
  • Cairo University
    Giza, 12613, Egypt
08

References and documents

Publications

  • El-Salam SA, Aboalnaga AA, Tawfik WA, Salah Fayed MM. Effect of gradually increasing force magnitude on the rate of canine retraction: a split mouth randomized controlled trial. BMC Oral Health. 2026 Apr 21;26(1):756. doi: 10.1186/s12903-026-08243-4. PubMed 42015068 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05643443
Lead sponsor
Cairo University
Responsible party
Shady Abd ElSalam Rizk ElEsh (Principal Investigator, Cairo University) — Principal investigator
First posted
Dec 8, 2022
Start date
Dec 2022 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Dec 8, 2022

Study contacts

Shady Abd ElSalam, PhD
Contact
dr.shadyabdelsalam@icloud.com
00201008815748
Mona Salah Fayed, Professor
study chair · Cairo University, Faculty of Dentistry

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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