Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3D Digital Model Analysis

NCT ID: NCT06292364

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-05
• Study Completion Date: 2024-12-05

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

Conditions

Relapse

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control group

beggs wrap around Retainer will be given to the patients immediately \[Just after debonding\].

Group Type: OTHER

immediate orthodontic retainer delivery

Intervention Type: OTHER

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

experimental group

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

Group Type: ACTIVE_COMPARATOR

delayed orthodontic retainer delivery

Intervention Type: OTHER

post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

Interventions

immediate orthodontic retainer delivery

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

Intervention Type: OTHER

delayed orthodontic retainer delivery

post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pgids Rohtak

Rohtak, Haryana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr. Rekha sharma MDS

Role: CONTACT

rajsringari@gmail.com

8076190296

Facility Contacts

Dr. Rekha Sharma, MDS

Role: primary

rajsringari@gmail.com

8076190296

Other Identifiers

PGIDS/BHRC/23/106

Identifier Type: -

Identifier Source: org_study_id