Clinical trial NCT06292364: Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3D Digital Model Analysis
Official title: "Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3 Dimensional Digital Model Analysis : A Prospective Clinical Trial "
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relapse
Keywords: orthodontic retention
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention .

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(Beggs wrap around retainer ) in one group and post 7 days retainer delivery( beggs wrap around retainer) 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:

1. Subjects who required extraction.
2. Optimal functional occlusion at end of treatment (PAR score \>70%).
3. Littles irregularity index (Pre-treatment \<6mm in both upper and lower arch).
4. Nonsurgical and non-orthopedic patients.
5. Non syndromic patients and no impaction of teeth except third molars.
6. Optimal periodontal condition and Good oral hygiene (probing depth \<3mm, gingival index score \<1
7. Good compliance regarding retainer wear.

Exclusion Criteria:

1. Subjects with incomplete orthodontic treatment.
2. TMJ disorder patients.
3. Any systemic disease affecting bone and general growth.
4. Patients with incomplete records.
5. Patient who fail to follow up or undergo complete treatment.
6. Patient with learning difficulties
7. Patients having antibiotic therapy within previous 3 months and used anti inflammatory drugs in the month before the study

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 - 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 - 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 - 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 - 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 - 6 month after debonding
Secondary outcomes:
measure: GCF - elisa
timeFrame: Tb - 1 month before debonding
measure: GCF - elisa
timeFrame: T0 - on the day of debonding
measure: GCF - elisa
timeFrame: T1 - 1 week after debonding
measure: GCF - elisa
timeFrame: T2 - 1 month after debonding
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Pgids Rohtak
state: Haryana
Study officials:
References: