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NCT Number: NCT06502886

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of oral and dental medicine, Cairo university

Cairo, 11553, Egypt

Location status: Recruiting

Location contact

Abdelaziz Taha Malek

PRINCIPAL_INVESTIGATOR

Orthodontic Department

CONTACT

[email protected]

0020223638755

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

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

Procedure

Combined bonded retainer and vacuum formed retainer

Other names: Fixed lingual retainer and vacuum formed retainer

Bonded lingual retainer

Procedure

Bonded retainer

Other names: Fixed lingual retainer

Primary outcomes

  1. Mandibular anterior segment alignment

    Time frame: 6 months

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

Secondary outcomes

  1. Maxillary anterior segment alignment

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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