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Clinical Trials/NCT03881813
NCT03881813CompletedNot Applicable

Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse

Dow University of Health Sciences2 sites in 1 country54 target enrollmentStarted: November 12, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
2
Primary Endpoint
Relapse tendency

Study Overview

Brief Summary

The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.

Detailed Description

54 subjects were recruited and divided into two groups by random allocation. Consents were obtained . Group 1 received fiber reinforced composite retainer and group 2 received multistranded stainless steel wire retainer. The patients were recalled at every three months interval for a period of 12 months. They were evaluated for number of fractures, failure pattern based on adhesive remnant index and relapse tendency by measuring little's irregularity index.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
14 Years to 30 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Subjects who have completed fixed appliance orthodontic treatment.
  • Subjects who have signed the consent forms.
  • Subjects who have accepted the terms and conditions of visiting after every three months for one year.
  • Non extraction cases in the mandibular arch with no IPR.
  • Patients without caries/ restoration/ fracture on the lower anterior teeth.
  • Patients with healthy periodontium with no periodontal disease at that time.

Exclusion Criteria

  • Presence of syndrome or systemic disease.
  • Patients taking medications/ drugs.
  • Patients with poor oral hygiene.
  • Patients with congenitally absent/ missing anterior teeth in the mandibular arch.
  • Patients with habit of clenching/ bruxism.
  • Patients with history of betel nut chewing.
  • Presence of occlusal interferences.

Arms & Interventions

Fiber reinforced composite retainers

Experimental

Fiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months.

Intervention: Orthodontic retainers (Device)

Multistranded stainless steel retainers

Experimental

Multistranded stainless steel retainers were inserted in group 2 and were evaluated after every 3 months for a follow up period of 3 months.

Intervention: Orthodontic retainers (Device)

Outcomes

Primary Outcomes

Relapse tendency

Time Frame: 12 months

It was measured using Little's irregularity index

Secondary Outcomes

  • Bond failure(12 months)
  • Failure Pattern(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nasreen Iqbal Nagani

Principal Investigator

Dow University of Health Sciences

Study Sites (2)

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