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Completed

NCT Number: NCT05458583

The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive

The aim of this study was to evaluate fixed retainers, bonded with either direct or indirect techniques using one- or two-step adhesives, in terms of periodontal status and failure rates.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Faculty of Dentistry Department of Orthodontics

Denizli, 20160, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Good treatment outcomes
  • good oral hygiene
  • No systemic or periodontal problems
  • No extraction or missing anterior teeth and restorations

Exclusion criteria

  • Patients unwilling to wear a fixed retainer

Treatment and study plan

Baseline periodontal measurements (T0)

Procedure

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.

Periodontal measurements (T1)

Procedure

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.

Periodontal measurements (T2)

Procedure

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.

Retainer failure rates

Procedure

A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.

Primary outcomes

  1. Plaque index measurements

    Time frame: at the bonding session

    Plaque index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at the bonding session based on the following scale: 0 (no plaque), 1 (a film of plaque adhering to the free gingival margin and adjacent area of the tooth), 2 (moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin which can be seen with the naked eye) and 3 (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  2. Plaque index measurements

    Time frame: 6 months (T1) after bonding

    Plaque index (PI) was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 6 months after bonding based on the following scale: 0 (no plaque), 1 (a film of plaque adhering to the free gingival margin and adjacent area of the tooth), 2 (moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin which can be seen with the naked eye) and 3 (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  3. Plaque index measurements

    Time frame: 12 months (T2) after bonding

    Plaque index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (no plaque), 1 (a film of plaque adhering to the free gingival margin and adjacent area of the tooth), 2 (moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin which can be seen with the naked eye) and 3 (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  4. Gingival index measurements

    Time frame: at the bonding session

    Gingival index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at bonding session based on the following scale: 0 (absence of inflammation), 1 (mild inflammation), 2 (moderate inflammation) and 3 (severe inflammation).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  5. Gingival index measurements

    Time frame: 6 months (T1) after bonding

    Gingival index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 6 months after bonding based on the following scale: 0 (absence of inflammation), 1 (mild inflammation), 2 (moderate inflammation) and 3 (severe inflammation).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  6. Gingival index measurements

    Time frame: 12 months (T2) after bonding

    Gingival index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (absence of inflammation), 1 (mild inflammation), 2 (moderate inflammation) and 3 (severe inflammation).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  7. Calculus index measurements

    Time frame: at bonding session

    Calculus index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at bonding session based on the following scale: 0 (no calculus present), 1 (supragingival calculus covering not more than one third of the exposed tooth surface), 2 (supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical portion of the tooth or both) and 3 (supragingival calculus covering more than two thirds of the exposed tooth surface or a continuous heavy band of subgingival calculus around the cervical portion of the tooth or both).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL).

  8. Calculus index measurements

    Time frame: 6 months after bonding

    Calculus index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 6 months after bonding based on the following scale: 0 (no calculus present), 1 (supragingival calculus covering not more than one third of the exposed tooth surface), 2 (supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical portion of the tooth or both) and 3 (supragingival calculus covering more than two thirds of the exposed tooth surface or a continuous heavy band of subgingival calculus around the cervical portion of the tooth or both).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL)

  9. Calculus index measurements

    Time frame: 12 months after bonding

    Calculus index was scored by a specialized periodontist on the mesiolingual, lingual, and distolingual sides of each tooth at 12 months after bonding based on the following scale: 0 (no calculus present), 1 (supragingival calculus covering not more than one third of the exposed tooth surface), 2 (supragingival calculus covering more than one third but not more than two thirds of the exposed tooth surface or the presence of individual flecks of subgingival calculus around the cervical portion of the tooth or both) and 3 (supragingival calculus covering more than two thirds of the exposed tooth surface or a continuous heavy band of subgingival calculus around the cervical portion of the tooth or both).

    All measurements were performed using acrylic stents to ensure reproducible placement of the periodontal probe (PCP 15 UNC, Hu-Friedy, Chicago, IL)

Secondary outcomes

  1. Failure rate

    Time frame: during 1-year follow-up

    A retainer with at least one composite pad detachment was considered to be a failure during a 1-year follow-up period. When there was no wire breakage or deformation, the tooth surfaces were cleaned and bonding was completed using a direct technique.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 14, 2022
Registry last updated
Jul 26, 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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