Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-29 @ 12:47 AM
Study NCT ID:
NCT04578704
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Sponsor:
University of Malaya
Organization:
Study Overview
Official Title:
Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bimaxillary dental proclination is the condition where the upper and lower dental arches are procline thus increase lip fullness. Since the aim of orthodontic treatment in bimaxillary proclination in to get flatten profile where the incisor inclinations are purposely reduced or interincisal angle are increased, therefore it is guarded for corrected dentition to maintain stable or not post orthodontic treatment.Therefore, this study is looking into evidence which is the best retainer to maintain stability of bimaxillary proclination cases following fixed appliances treatment.
Detailed Description:
Study title Stability of Bimaxillary Proclination Cases Following Fixed Appliances Treatment: A Randomized Control Trial
Study Population Pre-treatment of bimaxillary proclination patient who completed active orthodontic treatment with fixed appliances and are scheduled to debond at Orthodontic Clinic, Faculty of Dentistry, University of Malaya.
Study Design Randomized, prospective, single-center control trial. Three parallel arm groups of patients will be assigned for 3 types of retention methods; 1.VFR 2.Fixed bonded retainer 3.Double regime (bonded \& VFR)
Aim of study To determine the best mode of retention to maintain the stability of bimaxillary proclination cases treated by four premolars extraction and fixed appliances.
Specific Objectives
1. To measure the post treatment dental and soft tissue stability in the retention phase up to one-year post treatment
2. To compare the effectiveness the different types of retainers to maintain the stability of orthodontically corrected bimaxillary proclination
3. To determine the impact of the different types of retainers on the OHRQoL
Sample Size The sample size calculation was done using G\*power software version 3.1.The f-test, repeated measures ANOVA, within-between interaction were used.
Based on the effect size of 0.43 (Keating PJ 1986), maximum accuracy (power) of 80% (0.80), error of 5% (0.05), number of groups are 3, number of measurements are 2, correlation among repetitive measures is 0.5, nonsphericity correlation is 1, total number of 18 subjects needed for entire study. Allowing for 50% dropout, a final sample size of 27 subjects with 9 subjects per group will be used.
Study Duration September 2019 - Disember 2021
Study Population Pre-treatment of bimaxillary proclination patient who completed active orthodontic treatment with fixed appliances and are scheduled to debond at Orthodontic Clinic, Faculty of Dentistry, University of Malaya.
Study Design Randomized, prospective, single-center control trial. Three parallel arm groups of patients will be assigned for 3 types of retention methods; 1.VFR 2.Fixed bonded retainer 3.Double regime (bonded \& VFR)
Aim of study To determine the best mode of retention to maintain the stability of bimaxillary proclination cases treated by four premolars extraction and fixed appliances.
Specific Objectives
1. To measure the post treatment dental and soft tissue stability in the retention phase up to one-year post treatment
2. To compare the effectiveness the different types of retainers to maintain the stability of orthodontically corrected bimaxillary proclination
3. To determine the impact of the different types of retainers on the OHRQoL
Sample Size The sample size calculation was done using G\*power software version 3.1.The f-test, repeated measures ANOVA, within-between interaction were used.
Based on the effect size of 0.43 (Keating PJ 1986), maximum accuracy (power) of 80% (0.80), error of 5% (0.05), number of groups are 3, number of measurements are 2, correlation among repetitive measures is 0.5, nonsphericity correlation is 1, total number of 18 subjects needed for entire study. Allowing for 50% dropout, a final sample size of 27 subjects with 9 subjects per group will be used.
Study Duration September 2019 - Disember 2021
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: