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OpenTrials
Completed

NCT Number: NCT03881813

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

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.

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Key information

Conditions

Relapse Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University Of Health Sciences

Karachi, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthodontic retainers

Device

Orthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year.

Primary outcomes

  1. Relapse tendency

    Time frame: 12 months

    It was measured using Little's irregularity index

Secondary outcomes

  1. Bond failure

    Time frame: 12 months

    Number of bond failure was assessed at each visit.

  2. Failure Pattern

    Time frame: 12 months

    Type of failure pattern was assessed based on Adhesive remnant index.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2019
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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