Comparison of Canine Retraction Using Ni-ti Closed-coil Springs Vs Elastomeric Power Chains During Orthodontic Treatment

January 28, 2025 updated by: Munnal Gulzar

Comprehensive Comparison of Canine Retraction Using Nickel-titanium Closed-coil Springs Versus Elastomeric Power Chains During Orthodontic Treatment - A Split-mouth Randomized Controlled

The objective of this study is to compare the canine retraction rate (in mm with a 100 mm marked scale) using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months.

After the extraction of all first premolars under local anesthesia. For canine retraction, Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches.

Radiographic measurement (root resorption) and clinical measurements (canine retraction, plaque accumulation and gingival health) will be recorded at four points in time. First, at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

RATIONALE:

Premolar extraction followed by canine retraction is one of the common practices in orthodontics to treat malocclusion such as severe crowding and proclination of anterior teeth. It is essential to know methods and techniques that result in minimum or no adverse effects on roots of teeth and periodontal health. This will help the clinicians to choose the best method that will result in a faster and more physiological closure of extraction spaces. Moreover, to the best of our knowledge, limited studies have compared the effects of Ni-Ti closed-coil springs and elastomeric power chains on canine root resorption, gingival health and plaque accumulation. It is necessary to establish a comparison between these methods, as it can help clinicians to provide better care and enhance the overall effectiveness of orthodontic treatment.

OBJECTIVE:

Primary Objective: The objective of this study is to compare the canine retraction rate (in mm with a 100 mm marked scale) using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months.

Secondary Objective: This study will also include an assessment of canine root resorption (in mm using periapical radiograph), dental plaque accumulation and gingival health (according to indices mentioned below with CPI-TN probe) using Ni-Ti closed-coil springs versus elastomeric power chains during canine retraction in subjects with first premolar extractions over a period of three months.

HYPOTHESIS:

Null Hypothesis: There is no significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption, retraction rate, dental plaque accumulation and gingival health in subjects with first premolar extractions.

Alternate Hypothesis: There is a significant difference between Ni-Ti closed-coil spring and elastomeric power chain on the canine root resorption, retraction rate, dental plaque accumulation and gingival health in subjects with first premolar extractions.

DATA COLLECTION PROCEDURE:

After obtaining an approval from the Ethical Review Committee and taking informed consent and informed assent from the parents and child respectively, these patients will be recruited in the study as participants. Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study. Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study. After the extraction of all first premolars under local anesthesia, 0.018" stainless steel archwires will be inserted in the maxillary and mandibular arches. For canine retraction, Ni-Ti closed-coil springs and elastomeric power chains will be randomly allocated to the right and left quadrants of both arches. Radiographic measurement (root resorption) and clinical measurements (canine retraction, plaque accumulation and gingival health) will be recorded at four points in time. First, at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3). Canine retraction rate will be recorded by using a 100 mm marked scale. Data will be collected on an organized study proforma

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged between 13 - 40 years
  • Patients undergoing fixed orthodontic treatment
  • Patients requiring all first premolars extraction as part of orthodontic treatment
  • Patients with all permanent teeth present and erupted (except for second and third molars)
  • All patients who will sign the informed consent/assent form

Exclusion Criteria:

  • • Patients with systemic diseases that can affect tooth movements

    • Patients with uncontrolled periodontal disease
    • Patients with craniofacial syndromes
    • Pregnant or lactating mothers
    • Patients with bracket failures greater than three times per bracket during the study
    • Patients on medications that can affect tooth movements
    • Patients with Nickel allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ni-ti closed Coil spring
For canine retraction, Ni-Ti closed-coil springs will be randomly allocated to the right and left quadrants of both arches
Other: Ni-ti Closed-coil Spring
Ni-Ti closed-coil spring is a passive compressed spring made up of super elastic Nickel-titanium. Two eyelets are attached to each side of the coil to facilitate its application. The eyelets will be engaged in the hooks of the second premolar and canine brackets and will apply a force of 150 gm.
Other Names:
  • closing coil
  • closing coil spring
Active Comparator: Elastomeric power chain
For canine retraction, elastomeric power chains will be randomly allocated to the right and left quadrants of both arches
Other: Elastomeric Power chain
Elastomeric power chains are resilient and latex-free orthodontic materials. They are made up of elastic material and consist of many connected rings. Each ring is engaged in a bracket to apply a force of 175-300 gm.
Other Names:
  • Power chain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canine retraction rate
Time Frame: 3 months
The retraction rate of canine will be the distance travelled divided by the time interval needed for closure of spaces. It will be noted at four-time intervals i.e at the start of the canine retraction (T0), after first month (T1), second month (T2) and third month follow-up (T3).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Root resorption
Time Frame: 3 months
Root resorption is a decrease in root length and width due to an inflammatory process. In orthodontics, during tooth movement, areas of necrosis develop called hyalinized areas, which result in root resorption. Periapical radiographs will be taken to assess the amount of root resorption by determining the length of the tooth from the cusp tip to the root apex
3 months
Gingival health
Time Frame: 3 months
Gingival index is a grading system that is used to assess the health of the gingiva. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the compromised gingival health of the teeth.
3 months
Plaque index
Time Frame: 3 months
Plaque index is a grading system used to assess the amount of plaque present at the gingival margins and helps in assessing oral health. It consists of four grades including, Grade 0, 1, 2 and 3. The increase in grade indicates the increased amount of plaque along the gingiva.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Munnal Gulzar

Investigators

  • Principal Investigator: Mubassar Fida, BDS,FCPS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-9110-28139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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