Clinical trial NCT05879588: : "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 3 Days) Retainer Delivery
Official title: 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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relapse
Keywords: orthodontic retention
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 3 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

Eligibility criteria: Inclusion Criteria:

* 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).

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

Primary outcomes:
measure: overjet
timeFrame: T0-baseline on the day of debonding
measure: overjet
timeFrame: T1- 3 days after debonding
measure: overjet
timeFrame: T2- 1 month after debonding
measure: overjet
timeFrame: T3- 3 months after debonding
measure: overjet
timeFrame: T4- 6 months after debonding
measure: contact point displacement
timeFrame: T0-baseline on the day of debonding
measure: contact point displacement
timeFrame: T1- 3 days after debonding
measure: contact point displacement
timeFrame: T2- 1 month after debonding
measure: contact point displacement
timeFrame: T3- 3 months after debonding
measure: contact point displacement
timeFrame: T4- 6 months after debonding
measure: Overbite
timeFrame: T0- Baseline on the day of debonding
measure: Overbite
timeFrame: T1- 3 days after debonding
measure: Overbite
timeFrame: T2- 1 month after debonding
measure: Overbite
timeFrame: T3- 3 months after debonding
measure: Overbite
timeFrame: T4- 6 months after debonding
measure: Intermolar width
timeFrame: T0-baseline on the day of debonding
measure: Intermolar width
timeFrame: T1- 3 days after debonding
measure: Intermolar width
timeFrame: T2- 1 month after debonding
measure: Intermolar width
timeFrame: T3- 3 months after debonding
measure: Intermolar width
timeFrame: T4- 6 months after debonding
measure: Intercanine width
timeFrame: T0-baseline on the day of debonding
measure: Intercanine width
timeFrame: T1- 3 days after debonding
measure: Intercanine width
timeFrame: T2- 1 month after debonding
measure: Intercanine width
timeFrame: T3- 3 months after debonding
measure: Intercanine width
timeFrame: T4- 6 months after debonding
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
References: