Clinical Trials Directory

Trials / Unknown

UnknownNCT05612932

"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"

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Postgraduate Institute of Dental Sciences Rohtak · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

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

Conditions

Interventions

TypeNameDescription
OTHERimmediate orthodontic retainer deliverypost orthodontic treatment patients will be given orthodontic retainer immediately after debonding
OTHERdelayed orthodontic retainer deliverypost orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

Timeline

Start date
2022-05-25
Primary completion
2023-12-25
Completion
2024-04-25
First posted
2022-11-10
Last updated
2023-05-30

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05612932. Inclusion in this directory is not an endorsement.