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

Relapse Clinical Trial

Official title:

"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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612932
• Other study ID #: PGIDS/BHRC/22/34 CHIRAG K JAIN
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: April 25, 2024

Study information

• Verified date: May 2023
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Dr. Devender kumar, MDS
• Phone: 8950447738
• Email: Davenderkumar0195[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

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	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 - 3 month after debonding
Primary	Overjet	sagittal distance between upper and lower incisors	T4 - 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 - 3 month after debonding
Primary	contact point displacement	displacement of contact points in anterior teeth	T4 - 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 - 3 month after debonding
Primary	overbite	vertical overlap of upper and lower incisors	T4 - 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 - 3 month after debonding
Primary	intermolar width	transverse distance between the first molars	T4 - 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 - 3 month after debonding
Primary	intercanine width	transverse distance between the canine	T4 - 6 month after debonding