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

Primary Purpose

Periodontal Inflammation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baseline periodontal measurements (T0)
Periodontal measurements (T1)
Periodontal measurements (T2)
Retainer failure rates
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontal Inflammation focused on measuring failure rate, periodontal status, retainer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pamukkale University Faculty of Dentistry Department of Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Direct bonding with conventional adhesive

Direct bonding with one-step adhesive

Indirect bonding with conventional adhesive

Indirect bonding with one-step adhesive

Arm Description

The fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive

The fixed retainer was applied with direct bonding technique using one-step adhesive

The fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive

The fixed retainer was applied with indirect bonding technique using one-step adhesive

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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)
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)

Secondary Outcome Measures

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.

Full Information

First Posted
June 28, 2022
Last Updated
July 21, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05458583
Brief Title
The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive
Official Title
Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Inflammation
Keywords
failure rate, periodontal status, retainer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct bonding with conventional adhesive
Arm Type
Other
Arm Description
The fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive
Arm Title
Direct bonding with one-step adhesive
Arm Type
Other
Arm Description
The fixed retainer was applied with direct bonding technique using one-step adhesive
Arm Title
Indirect bonding with conventional adhesive
Arm Type
Other
Arm Description
The fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive
Arm Title
Indirect bonding with one-step adhesive
Arm Type
Other
Arm Description
The fixed retainer was applied with indirect bonding technique using one-step adhesive
Intervention Type
Procedure
Intervention Name(s)
Baseline periodontal measurements (T0)
Intervention Description
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.
Intervention Type
Procedure
Intervention Name(s)
Periodontal measurements (T1)
Intervention Description
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.
Intervention Type
Procedure
Intervention Name(s)
Periodontal measurements (T2)
Intervention Description
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.
Intervention Type
Procedure
Intervention Name(s)
Retainer failure rates
Intervention Description
A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.
Primary Outcome Measure Information:
Title
Plaque index measurements
Description
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
Title
Plaque index measurements
Description
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
Title
Plaque index measurements
Description
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
Title
Gingival index measurements
Description
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
Title
Gingival index measurements
Description
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
Title
Gingival index measurements
Description
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
Title
Calculus index measurements
Description
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
Title
Calculus index measurements
Description
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
Title
Calculus index measurements
Description
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
Secondary Outcome Measure Information:
Title
Failure rate
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Pamukkale University Faculty of Dentistry Department of Orthodontics
City
Denizli
ZIP/Postal Code
20160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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