An interventional study of immediate orthodontic retainer delivery and delayed orthodontic retainer delivery in Relapse, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Prevention
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 .
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
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 209 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
beggs wrap around Retainer will be given to the patients immediately \[Just after debonding\].
Other: immediate orthodontic retainer delivery
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 immediately after debonding
post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding
overjet
sagittal distance between upper and lower incisors
Time frame: T0 - baseline on the day of debonding
overjet
sagittal distance between upper and lower incisors
Time frame: T1 - 7 days after debonding
overjet
sagittal distance between upper and lower incisors
Time frame: T2 - 1 month after debonding
Overjet
sagittal distance between upper and lower incisors
Time frame: T3 - 6 month after debonding
contact point displacement
displacement of contact points in anterior teeth
Time frame: T0 - baseline on the day of debonding
contact point displacement
displacement of contact points in anterior teeth
Time frame: T1 - 7 days after debonding
contact point displacement
displacement of contact points in anterior teeth
Time frame: T2 - 1 month after debonding
contact point displacement
displacement of contact points in anterior teeth
Time frame: T3 - 6 month after debonding
overbite
vertical overlap of upper and lower incisors
Time frame: T0 - baseline on the day of debonding
overbite
vertical overlap of upper and lower incisors
Time frame: T1 - 7 days after debonding
overbite
vertical overlap of upper and lower incisors
Time frame: T2 - 1 month after debonding
overbite
vertical overlap of upper and lower incisors
Time frame: T3 - 6 month after debonding
intermolar width
transverse distance between the first molars
Time frame: T0 - baseline on the day of debonding
intermolar width
transverse distance between the first molars
Time frame: T1 - 7 days after debonding
intermolar width
transverse distance between the first molars
Time frame: T2 - 1 month after debonding
intermolar width
transverse distance between the first molars
Time frame: T3 - 6 month after debonding
intercanine width
transverse distance between the canine
Time frame: T0 - baseline on the day of debonding
intercanine width
transverse distance between the canine
Time frame: T1 - 7 days after debonding
intercanine width
transverse distance between the canine
Time frame: T2 - 1 month after debonding
intercanine width
transverse distance between the canine
Time frame: T3 - 6 month after debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Time frame: Tb - 1 month before debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Time frame: T0 - on the day of debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Time frame: T1 - 1 week after debonding
GCF - elisa
BALP AND CTX TYPE 1 BIOMARKER
Time frame: T2 - 1 month after debonding
Plan to share: No
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Postgraduate Institute of Dental Sciences Rohtak