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

"Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3 Dimensional Digital Model Analysis : A Prospective Clinical Trial "

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 .

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(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

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

Contacts and Locations

• Study Contact: Name: Dr. Rekha sharma MDS; Phone Number: 8076190296; Email: rajsringari@gmail.com

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • Pgids Rohtak
      • Contact: Dr. Rekha Sharma, MDS; Phone Number: 8076190296; Email: rajsringari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; beggs wrap around 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; beggs wrap around 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
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
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
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
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
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 - 6 month after debonding
contact point displacement	displacement of contact points in anterior teeth	T3 - 6 month after debonding
overbite	vertical overlap of upper and lower incisors	T3 - 6 month after debonding
intermolar width	transverse distance between the first molars	T3 - 6 month after debonding
intercanine width	transverse distance between the canine	T3 - 6 month after debonding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	Tb - 1 month before debonding
GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T0 - on the day of debonding
GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T1 - 1 week after debonding
GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T2 - 1 month after debonding

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2023
• Primary Completion (Estimated): November 5, 2024
• Study Completion (Estimated): December 5, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

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/23/106

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