The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive
Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedJuly 26, 2022
July 1, 2022
29 days
June 28, 2022
July 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Plaque index measurements
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).
at the bonding session
Plaque index measurements
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).
6 months (T1) after bonding
Plaque index measurements
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).
12 months (T2) after bonding
Gingival index measurements
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).
at the bonding session
Gingival index measurements
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 months (T1) after bonding
Gingival index measurements
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).
12 months (T2) after bonding
Calculus index measurements
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).
at bonding session
Calculus index measurements
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)
6 months after bonding
Calculus index measurements
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)
12 months after bonding
Secondary Outcomes (1)
Failure rate
during 1-year follow-up
Study Arms (4)
Direct bonding with conventional adhesive
OTHERThe fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive
Direct bonding with one-step adhesive
OTHERThe fixed retainer was applied with direct bonding technique using one-step adhesive
Indirect bonding with conventional adhesive
OTHERThe fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive
Indirect bonding with one-step adhesive
OTHERThe fixed retainer was applied with indirect bonding technique using one-step adhesive
Interventions
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.
A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.
Eligibility Criteria
You may qualify if:
- Good treatment outcomes
- good oral hygiene
- No systemic or periodontal problems
- No extraction or missing anterior teeth and restorations
You may not qualify if:
- \- Patients unwilling to wear a fixed retainer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University Faculty of Dentistry Department of Orthodontics
Denizli, 20160, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The investigator who performed the assessment of the periodontal status was blinded to study groups. Moreover, the person performing data entry and the statistician was blinded to the study groups.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 14, 2022
Study Start
February 3, 2021
Primary Completion
March 4, 2021
Study Completion
March 1, 2022
Last Updated
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share