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Clinical Trials/NCT05458583
NCT05458583
Completed
Not Applicable

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

Pamukkale University1 site in 1 country100 target enrollmentFebruary 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Inflammation
Sponsor
Pamukkale University
Enrollment
100
Locations
1
Primary Endpoint
Plaque index measurements
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 3, 2021
End Date
March 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serpil Cokakoglu

Assistant Professor

Pamukkale University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

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

  • Failure rate(during 1-year follow-up)

Study Sites (1)

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