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

NCT06502886 | Recruiting

• 1 other identifier: ORTH 3-3-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• Mandibular anterior segment alignment

  Using 3D models, mandibular anterior segment alignment will be measured by little irregularity index

  6 months

Secondary Outcomes (1)

• Maxillary anterior segment alignment

  6 months

Study Arms (2)

The intervention group

EXPERIMENTAL

Use bonded retainer combined with vacuum formed retainer

Procedure: combined protocol of retention (bonded lingual retainer and vacuum formed retainers)

The comparator group

ACTIVE COMPARATOR

Use bonded retainer

Procedure: Bonded lingual retainer

Interventions

combined protocol of retention (bonded lingual retainer and vacuum formed retainers) PROCEDURE

Combined bonded retainer and vacuum formed retainer

Also known as: Fixed lingual retainer and vacuum formed retainer

The intervention group

Bonded lingual retainer PROCEDURE

Bonded retainer

Also known as: Fixed lingual retainer

The comparator group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Good oral hygiene
• Patients whom the pre-treatment records (models) are available
• Good finishing criteria (ABO grading system)

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of oral and dental medicine, Cairo university

Cairo, 11553, Egypt

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded randomized clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 16, 2024
• Study Start: March 10, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)