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

NCT ID: NCT06502886

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-10

Study Completion Date

2025-03-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Orthodontic Appliance Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Single-blinded randomized clinical trial

Study Groups

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The intervention group

Use bonded retainer combined with vacuum formed retainer

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Combined bonded retainer and vacuum formed retainer

The comparator group

Use bonded retainer

Group Type ACTIVE_COMPARATOR

Bonded lingual retainer

Intervention Type PROCEDURE

Bonded retainer

Interventions

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

Combined bonded retainer and vacuum formed retainer

Intervention Type PROCEDURE

Bonded lingual retainer

Bonded retainer

Intervention Type PROCEDURE

Other Intervention Names

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Fixed lingual retainer and vacuum formed retainer Fixed lingual retainer

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdelaziz Taha Abdelaziz Malek

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of oral and dental medicine, Cairo university

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Orthodontic Department

Role: primary

0020223638755

Other Identifiers

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ORTH 3-3-10

Identifier Type: -

Identifier Source: org_study_id

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