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

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontal Inflammation

Intervention / Treatment
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* Procedure: Baseline periodontal measurements (T0)
* Procedure: Periodontal measurements (T1)
* Procedure: Periodontal measurements (T2)
* Procedure: Retainer failure rates


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Direct bonding with conventional adhesive<br>The fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive | Procedure: Baseline periodontal measurements (T0)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.<br>Procedure: Periodontal measurements (T1)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.<br>Procedure: Periodontal measurements (T2)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.<br>Procedure: Retainer failure rates<br>* A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.<br>|
| Other: Direct bonding with one-step adhesive<br>The fixed retainer was applied with direct bonding technique using one-step adhesive | Procedure: Baseline periodontal measurements (T0)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.<br>Procedure: Periodontal measurements (T1)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.<br>Procedure: Periodontal measurements (T2)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.<br>Procedure: Retainer failure rates<br>* A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.<br>|
| Other: Indirect bonding with conventional adhesive<br>The fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive | Procedure: Baseline periodontal measurements (T0)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.<br>Procedure: Periodontal measurements (T1)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.<br>Procedure: Periodontal measurements (T2)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.<br>Procedure: Retainer failure rates<br>* A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.<br>|
| Other: Indirect bonding with one-step adhesive<br>The fixed retainer was applied with indirect bonding technique using one-step adhesive | Procedure: Baseline periodontal measurements (T0)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.<br>Procedure: Periodontal measurements (T1)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.<br>Procedure: Periodontal measurements (T2)<br>* Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.<br>Procedure: Retainer failure rates<br>* A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate | 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. | during 1-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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failure rate, periodontal status, retainer