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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05458583
Enrollment
100
Registered
2022-07-14
Start date
2021-02-03
Completion date
2022-03-01
Last updated
2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Inflammation

Keywords

failure rate, periodontal status, retainer

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.

Interventions

PROCEDUREBaseline periodontal measurements (T0)

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.

PROCEDUREPeriodontal measurements (T1)

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.

PROCEDUREPeriodontal measurements (T2)

Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.

PROCEDURERetainer failure rates

A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plaque index measurementsat the bonding sessionPlaque 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).
Gingival index measurementsat the bonding sessionGingival 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).
Calculus index measurementsat bonding sessionCalculus 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).

Secondary

MeasureTime frameDescription
Failure rateduring 1-year follow-upA 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026