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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06292364
Other study ID # PGIDS/BHRC/23/106
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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