Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction Using Combined Retention Protocol

Evaluation of The Stability of Orthodontic Treatment After First Premolar Extraction in Adult Patients Using Bonded Retainer Versus Bonded Retainer Combined With Vacuum Formed Retainer : A Randomized Clinical Trial

The aim of this study is to compare between the stability of anterior and posterior segments in both arches using bonded lingual retainers versus a combined protocol of retention (bonded lingual retainer and vacuum formed retainers). The effect of different treatment changes achieved on the post-treatment stability will be studied in both groups.

Hypothesis: No difference between BR and BR+VFR regarding the stability of anterior segment alignment and posterior segment alignment and interdigitation

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Procedure: combined protocol of retention (bonded lingual retainer and vacuum formed retainers); Procedure: Bonded lingual retainer

Detailed Description

Retention is necessary to be done after orthodontic treatment. It aids to prevent the tendency for relapse of teeth toward their pretreatment position. Fixed or removable retention appliances can reduce the risk of relapse, but to date there is still limited evidence on treatment protocols, wearing time and duration. However, long-term retention with bonded lingual retainers is commonly recommended and often considered the gold standard (method of first choice) in orthodontic retention. Regardless of the expected benefits concerning tooth stabilization, aesthetic appearance and independency from the patient's compliance, there have been increasing numbers of reports on undesirable changes in tooth position in the presence of retainers. Since "active" lingual retainers are able to exert forces to teeth, they have been suspected of causing torque changes of adjacent incisors ("X-effect"). Therefore, several authors recommend to insert removable and fixed in both arches for maximum relapse prevention.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Recruiting
    • faculty of oral and dental medicine, Cairo university
    • Contact: Orthodontic Department; Phone Number: 0020223638755; Email: ortho@dentistry.cu.edu.eg
    • Principal Investigator: Abdelaziz Taha Malek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adult patients at the end of comprehensive orthodontic treatment after extraction of upper and lower first premolars and requiring subsequent application of a lingual and palatal bonded retainers
2. Good oral hygiene
3. Patients whom the pre-treatment records (models) are available
4. Good finishing criteria (ABO grading system)

Exclusion Criteria:

1. Non-extraction orthodontic treatment
2. Poor oral hygiene
3. Dental/congenital anomalies ex: Missing laterals, transposed canines, Cleft lip and palate/craniofacial syndromes
4. Poor finishing criteria (ABO grading system)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group; Use bonded retainer combined with vacuum formed retainer	Procedure: combined protocol of retention (bonded lingual retainer and vacuum formed retainers); Combined bonded retainer and vacuum formed retainer; Other Names: Fixed lingual retainer and vacuum formed retainer
Active Comparator: The comparator group; Use bonded retainer	Procedure: Bonded lingual retainer; Bonded retainer; Other Names: Fixed lingual retainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mandibular anterior segment alignment	Using 3D models, mandibular anterior segment alignment will be measured by little irregularity index	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary anterior segment alignment	Using 3D models, maxillary anterior segment alignment will be measured by little irregularity index	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ORTH 3-3-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All the members of the research team will have access to the study data. All the data will be secured to maintain confidentiality. No other parties are allowed to assess the results until the study is terminated and the conclusions are revealed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No