NCT05879601

Brief Summary

Orthodontic treatment goals can be expressed as achieving ideal tooth alignment, esthetic, functional occlusion and stability. Various occlusal changes occur after active phase of orthodontic treatment, these unwanted changes are called relapse. Reitan pointed out that major percentage of changes following active phase of treatment is seen within 24 hours. To alleviate the effect of relapse, retention is needed. There is little agreement among clinicians about orthodontic retention protocol due to insufficient evidence in the literature on 1. time of retainer delivery 2. unexpected post- treatment changes. 3.quantification of relapse tendency. The present study will be undertaken to assess the changes and compare if there is any difference in the movement of teeth in post orthodontic treatment cases with immediate and delayed (post 24 hours) retainer delivery. Thus help in deciding when should the retainer delivery is preffered.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

July 27, 2022

Last Update Submit

May 26, 2023

Conditions

Relapse

Keywords

Orthodontic Retention

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 - 24 hours 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 month after debonding

  • Overjet

    sagittal distance between upper and lower incisors

    T4 - 6 month 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 - 24 hours 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 month after debonding

  • contact point displacement

    displacement of contact points in anterior teeth

    T4 - 6 month 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 - 24 hours 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 month after debonding

  • overbite

    vertical overlap of upper and lower incisors

    T4 - 6 month 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 - 24 hours 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 month after debonding

  • intermolar width

    transverse distance between the first molars

    T4 - 6 month after debonding

  • intercanine width

    transverse distance between the canine

    T0 - baseline on the day of debonding

  • intercanine width

    transverse distance between the canine

    T1 - 24 hours after debonding

  • intercanine width

    transverse distance between the canine

    T2 - 1 month after debonding

  • intercanine width

    transverse distance between the canine

    T3 - 3 month after debonding

  • intercanine width

    transverse distance between the canine

    T4 - 6 month after debonding

Study Arms (2)

control group- immediate retainer delivery

OTHER

Retainer will be given to the patients immediately \[ Just after debonding\]

Other: immediate orthodontic retainer delivery

experimental group- delayed retainer delivery

ACTIVE COMPARATOR

Retainer will be given to the patient 24 hours post debonding.

Other: delayed orthodontic retainer delivery.

Interventions

immediate orthodontic retainer deliveryOTHER

post orthodontic treatment patients will be given orthodontic retainer immediately after debonding.

control group- immediate retainer delivery
delayed orthodontic retainer delivery.OTHER

post orthodontic treatment patients will be given orthodontic retainer after 24 hours of debonding.

experimental group- delayed retainer delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Manisha Kamal Kukreja, MDS

CONTACT

9215650617mk3pgids@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Assignment
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

Locations

IN(1)