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.

Study Overview

• Status: Completed
• Conditions: Relapse
• Intervention / Treatment: Device: Orthodontic retainers

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 74800
    • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fiber reinforced composite 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.	Device: Orthodontic retainers; 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.
Experimental: Multistranded stainless steel 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.	Device: Orthodontic retainers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse tendency	It was measured using Little's irregularity index	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bond failure	Number of bond failure was assessed at each visit.	12 months
Failure Pattern	Type of failure pattern was assessed based on Adhesive remnant index.	12 months

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Nasreen Nagani, BDS, DUHS

Publications and helpful links

General Publications

• Nagani NI, Ahmed I, Tanveer F, Khursheed HM, Farooqui WA. "Clinical comparison of bond failure rate between two types of mandibular canine-canine bonded orthodontic retainers- a randomized clinical trial". BMC Oral Health. 2020 Jun 29;20(1):180. doi: 10.1186/s12903-020-01167-7.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2017
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 17, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: alignment; fixed retainers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: DUHS/DR-0/2017/327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No