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

Relapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292364
• Other study ID #: PGIDS/BHRC/23/106
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: December 5, 2024

Study information

• Verified date: February 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Dr. Rekha sharma MDS
• Phone: 8076190296
• Email: rajsringari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 5, 2024
• Est. primary completion date: November 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Recurrence
• Relapse

Intervention

Other:
• immediate orthodontic retainer delivery
post orthodontic treatment patients will be given orthodontic retainer immediately after debonding
• delayed orthodontic retainer delivery
post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

Locations

Country	Name	City	State
India	Pgids Rohtak	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overjet	sagittal distance between upper and lower incisors	T0 - baseline on the day of debonding
Primary	overjet	sagittal distance between upper and lower incisors	T1 - 7 days after debonding
Primary	overjet	sagittal distance between upper and lower incisors	T2 - 1 month after debonding
Primary	Overjet	sagittal distance between upper and lower incisors	T3 - 6 month after debonding
Primary	contact point displacement	displacement of contact points in anterior teeth	T0 - baseline on the day of debonding
Primary	contact point displacement	displacement of contact points in anterior teeth	T1 - 7 days after debonding
Primary	contact point displacement	displacement of contact points in anterior teeth	T2 - 1 month after debonding
Primary	contact point displacement	displacement of contact points in anterior teeth	T3 - 6 month after debonding
Primary	overbite	vertical overlap of upper and lower incisors	T0 - baseline on the day of debonding
Primary	overbite	vertical overlap of upper and lower incisors	T1 - 7 days after debonding
Primary	overbite	vertical overlap of upper and lower incisors	T2 - 1 month after debonding
Primary	overbite	vertical overlap of upper and lower incisors	T3 - 6 month after debonding
Primary	intermolar width	transverse distance between the first molars	T0 - baseline on the day of debonding
Primary	intermolar width	transverse distance between the first molars	T1 - 7 days after debonding
Primary	intermolar width	transverse distance between the first molars	T2 - 1 month after debonding
Primary	intermolar width	transverse distance between the first molars	T3 - 6 month after debonding
Primary	intercanine width	transverse distance between the canine	T0 - baseline on the day of debonding
Primary	intercanine width	transverse distance between the canine	T1 - 7 days after debonding
Primary	intercanine width	transverse distance between the canine	T2 - 1 month after debonding
Primary	intercanine width	transverse distance between the canine	T3 - 6 month after debonding
Secondary	GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	Tb - 1 month before debonding
Secondary	GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T0 - on the day of debonding
Secondary	GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T1 - 1 week after debonding
Secondary	GCF - elisa	BALP AND CTX TYPE 1 BIOMARKER	T2 - 1 month after debonding