: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery
Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery-A Randomized Control Trial"
1 other identifier
interventional
40
1 country
1
Brief Summary
Maintaining teeth in their corrected position after orthodontic treatment is one of the most challenging part of orthodontic treatment and hence a period of stabilization termed as retention is provided after orthodontic treatment. Retention is one of the most important phase of orthodontic treatment that attempts to keep teeth in the corrected positions after treatment with orthodontic braces. Following literature search there is no scientific evidence for the timing of retainer delivery.The present study is designed to know if post orthodontic tooth movement vary with different time of retainer delivery and since there is unusual delay after debonding as the retainer is fabricated at the laboratory. Such a study will help us to find out within which time period the retainer should be delivered
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2022
CompletedFirst Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2024
CompletedMay 30, 2023
May 1, 2023
1.6 years
July 27, 2022
May 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (25)
overjet
sagittal distance between upper and lower incisors
T0-baseline on the day of debonding
overjet
sagittal distance between upper and lower incisors
T1- 3 days after debonding
overjet
sagittal distance between upper and lower incisors
T2- 1 month after debonding
overjet
sagittal distance between upper and lower incisors
T3- 3 months after debonding
overjet
sagittal distance between upper and lower incisors
T4- 6 months after debonding
contact point displacement
displacement of contact points in anterior teeth
T0-baseline on the day of debonding
contact point displacement
displacement of contact points in anterior teeth
T1- 3 days after debonding
contact point displacement
displacement of contact points in anterior teeth
T2- 1 month after debonding
contact point displacement
displacement of contact points in anterior teeth
T3- 3 months after debonding
contact point displacement
displacement of contact points in anterior teeth
T4- 6 months after debonding
Overbite
vertical overlap of upper and lower incisors
T0- Baseline on the day of debonding
Overbite
vertical overlap of upper and lower incisors
T1- 3 days after debonding
Overbite
vertical overlap of upper and lower incisors
T2- 1 month after debonding
Overbite
vertical overlap of upper and lower incisors
T3- 3 months after debonding
Overbite
vertical overlap of upper and lower incisors
T4- 6 months after debonding
Intermolar width
transverse distance between the first molars
T0-baseline on the day of debonding
Intermolar width
transverse distance between the first molars
T1- 3 days after debonding
Intermolar width
transverse distance between the first molars
T2- 1 month after debonding
Intermolar width
transverse distance between the first molars
T3- 3 months after debonding
Intermolar width
transverse distance between the first molars
T4- 6 months after debonding
Intercanine width
transverse distance between canine
T0-baseline on the day of debonding
Intercanine width
transverse distance between canine
T1- 3 days after debonding
Intercanine width
transverse distance between canine
T2- 1 month after debonding
Intercanine width
transverse distance between canine
T3- 3 months after debonding
Intercanine width
transverse distance between canine
T4- 6 months after debonding
Study Arms (2)
control group-immediate retainer delivery
OTHERRetainer will be given to the patients immediately \[Just after debonding\].
experimental group-delayed retainer delivery
ACTIVE COMPARATORRetainer will be delivered to the patients 3 days post debonding.
Interventions
post orthodontic treatment patients will be given orthodontic retainer immediately after debonding
post orthodontic treatment patients will be given orthodontic retainer after 3 days of debonding
Eligibility Criteria
You may qualify if:
- Adult orthodontic patients treated with 022\*028 MBT appliance with following sequence of wires- 014, 016, 16\*22, 17\*25, 19\*25 NiTi followed by 19\*25 SS.
- Treatment duration of 24-36 months with Optimal functional occlusion at end of treatment (PAR score \>70%).
- Class I bimax and Class II div I with pre-treatment Little's irregularity index \<6mm in both upper and lower arch.
- Nonsurgical and non-orthopedic patients.
- Non syndromic patients and no impaction of teeth except third molars.
- No previous orthodontic treatment.
- Optimal periodontal condition and Good oral hygiene.
- Good compliance regarding retainer wear (Cases who never missed more than 2 consecutive appointment and who reported with less no of breakages).
You may not qualify if:
- Subjects with incomplete orthodontic treatment.
- TMJ disorder patients.
- Any systemic disease affecting bone and general growth.
- Patients with incomplete records.
- Patient who fail to follow up or undergo complete treatment.
- Patient with learning difficulties
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
May 30, 2023
Study Start
May 25, 2022
Primary Completion
December 25, 2023
Study Completion
April 25, 2024
Last Updated
May 30, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share