Back to resultsEffectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Primary Purpose
Relapse
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Orthodontic retainers
Sponsored by
About this trial
This is an interventional prevention trial for Relapse focused on measuring fixed retainers, alignment
Eligibility Criteria
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.
Sites / Locations
- Dow University Of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fiber reinforced composite retainers
Multistranded stainless steel retainers
Arm Description
Fiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months.
Multistranded stainless steel retainers were inserted in group 2 and were evaluated after every 3 months for a follow up period of 3 months.
Outcomes
Primary Outcome Measures
Relapse tendency
It was measured using Little's irregularity index
Secondary Outcome Measures
Bond failure
Number of bond failure was assessed at each visit.
Failure Pattern
Type of failure pattern was assessed based on Adhesive remnant index.
Full Information
NCT ID
NCT03881813
First Posted
March 17, 2019
Last Updated
March 19, 2019
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03881813
Brief Title
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Official Title
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 12, 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse
Keywords
fixed retainers, alignment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fiber reinforced composite retainers
Arm Type
Experimental
Arm Description
Fiber reinforced composite retainers were inserted in group 1 and were evaluated after every 3 months for a follow up period of 3 months.
Arm Title
Multistranded stainless steel retainers
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Orthodontic retainers
Intervention Description
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 Outcome Measure Information:
Title
Relapse tendency
Description
It was measured using Little's irregularity index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bond failure
Description
Number of bond failure was assessed at each visit.
Time Frame
12 months
Title
Failure Pattern
Description
Type of failure pattern was assessed based on Adhesive remnant index.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasreen Nagani, BDS
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University Of Health Sciences
City
Karachi
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32600325
Citation
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.
Results Reference
derived
Learn more about this trial
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse
We'll reach out to this number within 24 hrs