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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Inflammation
• Intervention / Treatment: Procedure: Baseline periodontal measurements (T0); Procedure: Periodontal measurements (T1); Procedure: Periodontal measurements (T2); Procedure: Retainer failure rates

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20160
    • Pamukkale University Faculty of Dentistry Department of Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 3, 2021
• Primary Completion (ACTUAL): March 4, 2021
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (ACTUAL): July 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: periodontal status; failure rate; retainer
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: E-60116787-020-14577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No