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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06292364
Enrollment
40
Registered
2024-03-05
Start date
2023-11-05
Completion date
2024-12-05
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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Keywords

orthodontic retention

Brief 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 .

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(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

Interventions

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

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
contact point displacementT0 - baseline on the day of debondingdisplacement of contact points in anterior teeth
overjetT0 - baseline on the day of debondingsagittal distance between upper and lower incisors
OverjetT3 - 6 month after debondingsagittal distance between upper and lower incisors
intercanine widthT0 - baseline on the day of debondingtransverse distance between the canine
overbiteT0 - baseline on the day of debondingvertical overlap of upper and lower incisors
intermolar widthT0 - baseline on the day of debondingtransverse distance between the first molars

Secondary

MeasureTime frameDescription
GCF - elisaTb - 1 month before debondingBALP AND CTX TYPE 1 BIOMARKER

Countries

India

Contacts

Primary ContactDr. Rekha sharma MDS
rajsringari@gmail.com8076190296

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026