An interventional study of Baseline periodontal measurements (T0) and Periodontal measurements (T1) in Periodontal Inflammation, sponsored by Pamukkale University. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by Pamukkale University · Not applicable, Interventional, and Other
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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This study's enrollment of 100 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
The fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive
Procedure: Baseline periodontal measurements (T0) · Procedure: Periodontal measurements (T1) · Procedure: Periodontal measurements (T2) · Procedure: Retainer failure rates
The fixed retainer was applied with direct bonding technique using one-step adhesive
Procedure: Baseline periodontal measurements (T0) · Procedure: Periodontal measurements (T1) · Procedure: Periodontal measurements (T2) · Procedure: Retainer failure rates
The fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive
Procedure: Baseline periodontal measurements (T0) · Procedure: Periodontal measurements (T1) · Procedure: Periodontal measurements (T2) · Procedure: Retainer failure rates
The fixed retainer was applied with indirect bonding technique using one-step adhesive
Procedure: Baseline periodontal measurements (T0) · Procedure: Periodontal measurements (T1) · Procedure: Periodontal measurements (T2) · Procedure: Retainer failure rates
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 12 months after bonding
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.
Time frame: during 1-year follow-up
Plan to share: No
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Pamukkale University