Clinical trial NCT05612932: "Comparative Evaluation of 3 Dimensional Changes of Dentition in Post Orthodontic Patients With Immediate vs Delayed (Post 7 Days) Retainer Delivery
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"
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: 2022-11-10
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: 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.

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

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 - 7 days after debonding
measure: Overjet
timeFrame: T2 - 1 month after debonding
measure: Overjet
timeFrame: T3 - 3 month after debonding
measure: Overjet
timeFrame: T4 - 6 month after debonding
measure: contact point displacement
timeFrame: T0 - baseline on the day of debonding
measure: contact point displacement
timeFrame: T1 - 7 days after debonding
measure: contact point displacement
timeFrame: T2 - 1 month after debonding
measure: contact point displacement
timeFrame: T3 - 3 month after debonding
measure: contact point displacement
timeFrame: T4 - 6 month after debonding
measure: overbite
timeFrame: T0 - baseline on the day of debonding
measure: overbite
timeFrame: T1 - 7 days after debonding
measure: overbite
timeFrame: T2 - 1 month after debonding
measure: overbite
timeFrame: T3 - 3 month after debonding
measure: overbite
timeFrame: T4 - 6 month after debonding
measure: intermolar width
timeFrame: T0 - baseline on the day of debonding
measure: intermolar width
timeFrame: T1 - 7 days after debonding
measure: intermolar width
timeFrame: T2 - 1 month after debonding
measure: intermolar width
timeFrame: T3 - 3 month after debonding
measure: intermolar width
timeFrame: T4 - 6 month after debonding
measure: intercanine width
timeFrame: T0 - baseline on the day of debonding
measure: intercanine width
timeFrame: T1 - 7 days after debonding
measure: intercanine width
timeFrame: T2 - 1 month after debonding
measure: intercanine width
timeFrame: T3 - 3 month after debonding
measure: intercanine width
timeFrame: T4 - 6 month after debonding
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
References: