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

NCT06292364 | Recruiting

• 1 other identifier: PGIDS/BHRC/23/106
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Relapse

Keywords

orthodontic retention

Outcome Measures

Primary Outcomes (20)

• overjet

  sagittal distance between upper and lower incisors

  T0 - baseline on the day of debonding

• overjet

  sagittal distance between upper and lower incisors

  T1 - 7 days after debonding

• overjet

  sagittal distance between upper and lower incisors

  T2 - 1 month after debonding

• Overjet

  sagittal distance between upper and lower incisors

  T3 - 6 month after debonding

• contact point displacement

  displacement of contact points in anterior teeth

  T0 - baseline on the day of debonding

• contact point displacement

  displacement of contact points in anterior teeth

  T1 - 7 days after debonding

• contact point displacement

  displacement of contact points in anterior teeth

  T2 - 1 month after debonding

• contact point displacement

  displacement of contact points in anterior teeth

  T3 - 6 month after debonding

• overbite

  vertical overlap of upper and lower incisors

  T0 - baseline on the day of debonding

• overbite

  vertical overlap of upper and lower incisors

  T1 - 7 days after debonding

• overbite

  vertical overlap of upper and lower incisors

  T2 - 1 month after debonding

• overbite

  vertical overlap of upper and lower incisors

  T3 - 6 month after debonding

• intermolar width

  transverse distance between the first molars

  T0 - baseline on the day of debonding

• intermolar width

  transverse distance between the first molars

  T1 - 7 days after debonding

• intermolar width

  transverse distance between the first molars

  T2 - 1 month after debonding

• intermolar width

  transverse distance between the first molars

  T3 - 6 month after debonding

• intercanine width

  transverse distance between the canine

  T0 - baseline on the day of debonding

• intercanine width

  transverse distance between the canine

  T1 - 7 days after debonding

• intercanine width

  transverse distance between the canine

  T2 - 1 month after debonding

• intercanine width

  transverse distance between the canine

  T3 - 6 month after debonding

Secondary Outcomes (4)

• GCF - elisa

  Tb - 1 month before debonding

• GCF - elisa

  T0 - on the day of debonding

• GCF - elisa

  T1 - 1 week after debonding

• GCF - elisa

  T2 - 1 month after debonding

Study Arms (2)

control group

OTHER

beggs wrap around Retainer will be given to the patients immediately \[Just after debonding\].

Other: immediate orthodontic retainer delivery

experimental group

ACTIVE COMPARATOR

beggs wrap around Retainer will be delivered to the patients 7 days post debonding.

Other: delayed orthodontic retainer delivery

Interventions

immediate orthodontic retainer delivery OTHER

post orthodontic treatment patients will be given orthodontic retainer immediately after debonding

control group

delayed orthodontic retainer delivery OTHER

post orthodontic treatment patients will be given orthodontic retainer after 7 days of debonding

experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who required extraction.
• Optimal functional occlusion at end of treatment (PAR score \>70%).
• Littles irregularity index (Pre-treatment \<6mm in both upper and lower arch).
• Nonsurgical and non-orthopedic patients.
• Non syndromic patients and no impaction of teeth except third molars.
• Optimal periodontal condition and Good oral hygiene (probing depth \<3mm, gingival index score \<1
• Good compliance regarding retainer wear.

You may not qualify if:

• 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
• Patients having antibiotic therapy within previous 3 months and used anti inflammatory drugs in the month before the study

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Pgids Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Rekha sharma MDS

CONTACT

8076190296; rajsringari@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: November 5, 2023
• Primary Completion: November 5, 2024
• Study Completion: December 5, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)