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

"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"

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.

Study Overview

• Status: Recruiting
• Conditions: Relapse
• Intervention / Treatment: Other: immediate orthodontic retainer delivery; Other: delayed orthodontic retainer delivery

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Devender kumar, MDS; Phone Number: 8950447738; Email: Davenderkumar0195@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS
      • Contact: devender kumar, MDS; Phone Number: 8950447738; Email: Davenderkumar0195@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overjet	sagittal distance between upper and lower incisors	T0 - baseline on the day of debonding
Overjet	sagittal distance between upper and lower incisors	T1 - 7 days after debonding
Overjet	sagittal distance between upper and lower incisors	T2 - 1 month after debonding
Overjet	sagittal distance between upper and lower incisors	T3 - 3 month after debonding
Overjet	sagittal distance between upper and lower incisors	T4 - 6 month after debonding
contact point displacement	displacement of contact points in anterior teeth	T0 - baseline on the day of debonding
contact point displacement	displacement of contact points in anterior teeth	T1 - 7 days after debonding
contact point displacement	displacement of contact points in anterior teeth	T2 - 1 month after debonding
contact point displacement	displacement of contact points in anterior teeth	T3 - 3 month after debonding
contact point displacement	displacement of contact points in anterior teeth	T4 - 6 month after debonding
overbite	vertical overlap of upper and lower incisors	T0 - baseline on the day of debonding
overbite	vertical overlap of upper and lower incisors	T1 - 7 days after debonding
overbite	vertical overlap of upper and lower incisors	T2 - 1 month after debonding
overbite	vertical overlap of upper and lower incisors	T3 - 3 month after debonding
overbite	vertical overlap of upper and lower incisors	T4 - 6 month after debonding
intermolar width	transverse distance between the first molars	T0 - baseline on the day of debonding
intermolar width	transverse distance between the first molars	T1 - 7 days after debonding
intermolar width	transverse distance between the first molars	T2 - 1 month after debonding
intermolar width	transverse distance between the first molars	T3 - 3 month after debonding
intermolar width	transverse distance between the first molars	T4 - 6 month after debonding
intercanine width	transverse distance between the canine	T0 - baseline on the day of debonding
intercanine width	transverse distance between the canine	T1 - 7 days after debonding
intercanine width	transverse distance between the canine	T2 - 1 month after debonding
intercanine width	transverse distance between the canine	T3 - 3 month after debonding
intercanine width	transverse distance between the canine	T4 - 6 month after debonding

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): December 25, 2023
• Study Completion (Estimated): April 25, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: orthodontic retention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: PGIDS/BHRC/22/34 CHIRAG K JAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No