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

Periodontal Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05458583
• Other study ID #: E-60116787-020-14577
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Periodontal Inflammation

Intervention

Procedure:
• Baseline periodontal measurements (T0)
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.
• Periodontal measurements (T1)
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.
• Periodontal measurements (T2)
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.
• Retainer failure rates
A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.

Locations

Country	Name	City	State
Turkey	Pamukkale University Faculty of Dentistry Department of Orthodontics	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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