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

NCT ID: NCT06567730

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-11-30

Brief Summary

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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).

Detailed Description

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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

Conditions

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Root Resorption Plaque Accumulation Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ni-ti Closed-coil Spring

Intervention Type OTHER

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.

Elastomeric power chain

For canine retraction, elastomeric power chains will be randomly allocated to the right and left quadrants of both arches

Group Type ACTIVE_COMPARATOR

Elastomeric Power chain

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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closing coil closing coil spring Power chain

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Munnal Gulzar

OTHER

Sponsor Role lead

Responsible Party

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Munnal Gulzar

Co-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mubassar Fida, BDS,FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Central Contacts

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Munnal Gulzar, BDS

Role: CONTACT

03343536106

Mubassar Fida, BDS,FCPS

Role: CONTACT

021-34866641

References

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Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.

Reference Type BACKGROUND
PMID: 36464569 (View on PubMed)

Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.

Reference Type BACKGROUND
PMID: 25657985 (View on PubMed)

Makhlouf M, Aboul-Ezz A, Fayed MS, Hafez H. Evaluating the Amount of Tooth Movement and Root Resorption during Canine Retraction with Friction versus Frictionless Mechanics Using Cone Beam Computed Tomography. Open Access Maced J Med Sci. 2018 Feb 5;6(2):384-388. doi: 10.3889/oamjms.2018.066. eCollection 2018 Feb 15.

Reference Type BACKGROUND
PMID: 29531610 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2024-9110-28139

Identifier Type: -

Identifier Source: org_study_id

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