"Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 7 Days) Retainer Delivery

Sponsor
Postgraduate Institute of Dental Sciences Rohtak (Other)
Overall Status
Recruiting
CT.gov ID
NCT05612932
Collaborator
(none)
40
1
2
12
3.3

Study Details

Study Description

Brief Summary

After orthodontic treatment, relapse is inevitable and is defined as a movement towards the initial state which is undesirable. To prevent relapse, a phase of retention is required. Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result".

Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer. There is an unusual delay after debonding in retainer delivery as the retainer is fabricated at the laboratory. Such the present study will help us to find out within which time period the retainer should be delivered.

Condition or Disease Intervention/Treatment Phase
  • Other: immediate orthodontic retainer delivery
  • Other: delayed orthodontic retainer delivery
N/A

Detailed Description

The proposed study will be a prospective, non-pharmacological, single blind, randomized clinical trial to evaluate if there is a difference in transverse (X-axis), A-P(Y-axis) and Vertical plane(Z-axis) of dentition in two group of post orthodontic treatment patients with immediate retainer delivery in one group and post 7 days retainer delivery in other group of patients. The present study will be conducted in the Department of Orthodontic and Dentofacial Orthopedics, P.G.I.D.S, Pt. B.D Sharma University of health sciences, Rohtak. The study will be carried out after the institutional approval obtained from ethical committee.

A sample size of 18 patients was calculated keeping confidence interval 95% with power 80%. Accounting for a 10% drop out rate, 20 patients will be enrolled in each group. Patient will be randomly allocated to the study group by a person not involved in the trial using computer generated randomization list. Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.Changes in the tooth movement in transverse(X-axis), A-P(Y-axis), Vertical plane(Z-axis) will be compared in terms of intercanine width, intermolar width, overjet, overbite and contact point displacement between the two groups at following time intervals. These parameters will be charted at T0, T1, T2,T3 and T4 for each patient.

T0 - Baseline records, at the time of debonding. T1 - Records obtained at the time of retainer delivery. T2 - Records obtained after 1 month of retainer delivery. T3 - Records obtained after 3 months of retainer delivery. T4 - Records obtained after 6 months of retainer delivery

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
"Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 7 Days) Retainer Delivery-A Randomized Control Trial"
Actual Study Start Date :
May 25, 2022
Anticipated Primary Completion Date :
Apr 25, 2023
Anticipated Study Completion Date :
May 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: control group-immediate retainer delivery

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

Other: immediate orthodontic retainer delivery
post orthodontic treatment patients will be given orthodontic retainer immediately after debonding

Active Comparator: experimental group- delayed retainer delivery

Retainer will be delivered to the patients 7 days post debonding.

Other: delayed orthodontic retainer delivery
post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

Outcome Measures

Primary Outcome Measures

  1. Overjet [T0 - baseline on the day of debonding]

    sagittal distance between upper and lower incisors

  2. Overjet [T1 - 7 days after debonding]

    sagittal distance between upper and lower incisors

  3. Overjet [T2 - 1 month after debonding]

    sagittal distance between upper and lower incisors

  4. Overjet [T3 - 3 month after debonding]

    sagittal distance between upper and lower incisors

  5. Overjet [T4 - 6 month after debonding]

    sagittal distance between upper and lower incisors

  6. contact point displacement [T0 - baseline on the day of debonding]

    displacement of contact points in anterior teeth

  7. contact point displacement [T1 - 7 days after debonding]

    displacement of contact points in anterior teeth

  8. contact point displacement [T2 - 1 month after debonding]

    displacement of contact points in anterior teeth

  9. contact point displacement [T3 - 3 month after debonding]

    displacement of contact points in anterior teeth

  10. contact point displacement [T4 - 6 month after debonding]

    displacement of contact points in anterior teeth

  11. overbite [T0 - baseline on the day of debonding]

    vertical overlap of upper and lower incisors

  12. overbite [T1 - 7 days after debonding]

    vertical overlap of upper and lower incisors

  13. overbite [T2 - 1 month after debonding]

    vertical overlap of upper and lower incisors

  14. overbite [T3 - 3 month after debonding]

    vertical overlap of upper and lower incisors

  15. overbite [T4 - 6 month after debonding]

    vertical overlap of upper and lower incisors

  16. intermolar width [T0 - baseline on the day of debonding]

    transverse distance between the first molars

  17. intermolar width [T1 - 7 days after debonding]

    transverse distance between the first molars

  18. intermolar width [T2 - 1 month after debonding]

    transverse distance between the first molars

  19. intermolar width [T3 - 3 month after debonding]

    transverse distance between the first molars

  20. intermolar width [T4 - 6 month after debonding]

    transverse distance between the first molars

  21. intercanine width [T0 - baseline on the day of debonding]

    transverse distance between the canine

  22. intercanine width [T1 - 7 days after debonding]

    transverse distance between the canine

  23. intercanine width [T2 - 1 month after debonding]

    transverse distance between the canine

  24. intercanine width [T3 - 3 month after debonding]

    transverse distance between the canine

  25. intercanine width [T4 - 6 month after debonding]

    transverse distance between the canine

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult orthodontic patients treated with 022028 MBT appliance with following sequence of wires- 014, 016, 1622, 1725, 1925 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).

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PGIDS Rohtak Haryana India 124001

Sponsors and Collaborators

  • Postgraduate Institute of Dental Sciences Rohtak

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Postgraduate Institute of Dental Sciences Rohtak
ClinicalTrials.gov Identifier:
NCT05612932
Other Study ID Numbers:
  • PGIDS/BHRC/22/34 CHIRAG K JAIN
First Posted:
Nov 10, 2022
Last Update Posted:
Nov 10, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Postgraduate Institute of Dental Sciences Rohtak
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022