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Not yet recruitingNCT07116954Updated Aug 12, 2025

Root Resorption and Alveolar Bone Changes in the Maxillary Canine Retraction Using Ni Ti Closed-coil Springs Versus Elastomeric Chains (A Split -Mouth Cone Beam CT Study)

An interventional study of Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group. and Canin retraction with NiTi Closed-Coil Springs and elastomeric chains in Orthodontic Patients Indicated for Upper First Premolar Extraction and Orthodontic Patients Indicated for Maxillary Canine Retraction, sponsored by Al-Azhar University. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study summary

This study will be carried out to asses root resorption and alveolar bone changes in the maxillary canine retraction using NiTi closed-coil springs versus elastomeric chains with cone beam CT

02

Conditions studied

  • Orthodontic Patients Indicated for Upper First Premolar Extraction
  • Orthodontic Patients Indicated for Maxillary Canine Retraction

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Keywords

  • Niti coil springs
  • Canine Retraction
  • Elastomeric Chains
  • Root resorption
  • CBCT
03

In context

Root Resorption

43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.

This study's planned enrollment of 22 is below the median of 29 across 36 interventional studies indexed under Root Resorption.

Browse Root Resorption studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patients aged 16 years or older

    • Patients indicated for fixed orthodontic appliances
    • Patients indicated for bilateral extraction of maxillary first premolars
    • Patients who have not undergone any previous orthodontic treatment

Exclusion criteria

  • Patients with a history of craniofacial trauma, anomalies, or congenital defects

    • Patients currently taking anticoagulant drugs affecting bone metabolism
    • Patients with a history of trauma or pathology involving the maxillary canines
    • Patients with periodontally compromised teeth
05

Study design

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

Study arms

  • Experimental
    Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be use

    Procedure: Twenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group. · Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains

  • Experimental
    Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on

    Procedure: Canin retraction with NiTi Closed-Coil Springs and elastomeric chains

Interventions

  • ProcedureTwenty-Two adult Patients who indicated for bilateral maxillary first premolar extraction will be randomly assigned into two equal group.

    Group1: Elastomeric chains will be used on the right side, and NiTi closed-coil springs will be used on the left side. Group2: NiTi closed-coil springs will be used on the right side, Elastomeric chains will be used on the left side.

  • ProcedureCanin retraction with NiTi Closed-Coil Springs and elastomeric chains

    Comparison between canine retraction using NiTi closed-coil springs versus elastomeric chains

06

What researchers measure

Primary outcomes

  1. Change in Apical Root Length After Canine Retraction

    Measurement of apical root length (in millimeters) using CBCT images at T1 and T2 to assess root resorption on both retraction methods.

    Time frame: Baseline (prior to canine retraction) and 6 months after retraction

  2. Change in Alveolar Bone Thickness After Canine Retraction

    Quantitative measurement of alveolar bone thickness (in millimeters) using CBCT images taken at baseline (T1) and post-treatment (T2) in both NiTi closed-coil spring and elastomeric chain sides.

    Time frame: Baseline (prior to canine retraction) and 6 months after retraction

Secondary outcomes

  1. Change in Probing Depth

    Measurement of probing depth (in millimeters) on both sides at baseline and 6 months

    Time frame: Baseline and 6 months post-treatment

  2. Change in Plaque Index

    Scoring of plaque accumulation using the Silness-Löe Plaque Index (score range: 0 to 3; higher score = worse outcome)

    Time frame: Baseline and 6 months post-treatment

  3. Change in Bleeding Index

    Evaluation using the Gingival Bleeding Index (score range: 0 to 3; higher score = worse outcome)

    Time frame: Baseline and 6 months post-treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD), including CBCT-based measurements of alveolar bone height and root resorption, will be shared. Data will be available beginning 6 months after study completion via a secure external repository (link will be provided in the References section). Access will be granted to researchers upon request and subject to approval.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07116954
Responsible party
Ahmed Mohamed Hassan Mahdy (Principal Investigator (Postgraduate Researcher in Orthodontics), Al-Azhar University) — Principal investigator
First posted
Aug 12, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 12, 2025

Study contacts

Ahmed Mohamed Hassan Mahdy, Bds
Contact
Ah4723045@gmail.com
+201119808935

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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