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Completed

NCT Number: NCT05340595

Effect of Primer Application on the Lingual Retainer

Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.

Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.

The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P < 0.05.

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Key information

Age range

11 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals who will continue to the retention phase after fixed orthodontic treatment,
  • Presence of all mandibular incisor and canine teeth,
  • Good oral hygiene,
  • No caries,
  • No fractures,
  • Healthy periodontal condition,
  • No restorations,
  • No previous bonded retainer,
  • No traumatic parafunctional habits such as bruxism.

Exclusion criteria

-

Treatment and study plan

Orthodontic retainer bonding

Other

Self-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces.

Primary outcomes

  1. Bond Failure Rate of a Mandibular Bonded Lingual Retainer

    Time frame: 24 months

    Bond Failure Rate of a Mandibular Bonded Lingual Retainer

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Collaborators

  • Sabahat Yazıcıoğlu

Registry information

Official study title

Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 22, 2022
Registry last updated
Apr 28, 2022

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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