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

Not Applicable

Completed

• Conditions: Relapse
• Interventions: Device: Orthodontic retainers

• Registration Number: NCT03881813
• Lead Sponsor: Dow University of Health Sciences

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 Timeline

• Study Start: 2017-11-12
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-17
• Last Update Submitted: 2019-03-19
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multistranded stainless steel retainers	Orthodontic retainers	Multistranded stainless steel retainers were inserted in group 2 and were evaluated after every 3 months for a follow up period of 3 months.
Fiber reinforced composite retainers	Orthodontic retainers	Fiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months.

Primary Outcome Measures

Name	Time	Method
Relapse tendency	12 months	It was measured using Little's irregularity index

Secondary Outcome Measures

Name	Time	Method
Bond failure	12 months	Number of bond failure was assessed at each visit.
Failure Pattern	12 months	Type of failure pattern was assessed based on Adhesive remnant index.

Trial Locations

Locations (1)

Dow University Of Health Sciences; 🇵🇰 Karachi, Pakistan