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

NCT ID: NCT03881813

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-12

Study Completion Date

2019-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Orthodontic retainers

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Orthodontic retainers

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nasreen Iqbal Nagani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nasreen Nagani, BDS

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dow University Of Health Sciences

Karachi, , Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32600325 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DUHS/DR-0/2017/327

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Essix Retainer vs Hawley Retainer
NCT01583933 UNKNOWN PHASE3