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Clinical Trials/NCT06567730
NCT06567730Not yet recruitingNot Applicable

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

Munnal Gulzar0 sites46 target enrollmentStarted: March 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
46
Primary Endpoint
Canine retraction rate

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Root resorption(3 months)
  • Gingival health(3 months)
  • Plaque index(3 months)

Investigators

Sponsor
Munnal Gulzar
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Munnal Gulzar

Co-Investigator

Aga Khan University Hospital, Pakistan

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