Periodontal InflammationNCT05458583
The Periodontal Status and Failure Rates With Different Retainer Bonding Techniques Using One-step Adhesive
A study testing Baseline periodontal measurements (T0), Periodontal measurements (T1) and Periodontal measurements (T2) in people with Periodontal Inflammation, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Inflammation
- What is being tested?
- Baseline periodontal measurements (T0), Periodontal measurements (T1) and Periodontal measurements (T2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Good treatment outcomes
- good oral hygiene
- No systemic or periodontal problems
- No extraction or missing anterior teeth and restorations
Who cannot join
- Patients unwilling to wear a fixed retainer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry Department of Orthodontics
Denizli, 20160
About this study
Official title: 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.
- Conditions
- Periodontal Inflammation
- Being tested
- Baseline periodontal measurements (T0), Periodontal measurements (T1), Periodontal measurements (T2), Retainer failure rates
- Keywords
- failure rate, periodontal status, retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline periodontal measurements (T0)Procedure or surgery
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session.
Periodontal measurements (T1)Procedure or surgery
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding.
Periodontal measurements (T2)Procedure or surgery
Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding.
Retainer failure ratesProcedure or surgery
A retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Direct bonding with conventional adhesive | Other | The fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive Receives: Procedure: Baseline periodontal measurements (T0); Procedure: Periodontal measurements (T1); Procedure: Periodontal measurements (T2); Procedure: Retainer failure rates |
| Direct bonding with one-step adhesive | Other | The fixed retainer was applied with direct bonding technique using one-step adhesive Receives: Procedure: Baseline periodontal measurements (T0); Procedure: Periodontal measurements (T1); Procedure: Periodontal measurements (T2); Procedure: Retainer failure rates |
| Indirect bonding with conventional adhesive | Other | The fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive Receives: Procedure: Baseline periodontal measurements (T0); Procedure: Periodontal measurements (T1); Procedure: Periodontal measurements (T2); Procedure: Retainer failure rates |
| Indirect bonding with one-step adhesive | Other | The fixed retainer was applied with indirect bonding technique using one-step adhesive Receives: Procedure: Baseline periodontal measurements (T0); Procedure: Periodontal measurements (T1); Procedure: Periodontal measurements (T2); Procedure: Retainer failure rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 12 months after bonding
Secondary outcomes (1)
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.
Measured: during 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start3 Feb 2021
- Primary completion4 Mar 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal InflammationStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Cokakoglu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458583
- Sponsor's protocol ID
- E-60116787-020-14577
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Periodontal Status and Failure Rates With Different Retainer Bonding Methods and Adhesives: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05458583
- Acronym / sponsor ID
- E-60116787-020-14577
- Conditions
- Periodontal Inflammation
- Keywords
- failure rate, periodontal status, retainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct bonding with conventional adhesive | Other | Procedure: Baseline periodontal measurements (T0), Procedure: Periodontal measurements (T1), Procedure: Periodontal measurements (T2), Procedure: Retainer failure ratesThe fixed retainer was applied with direct bonding technique using two-step (conventional) adhesive |
| Direct bonding with one-step adhesive | Other | Procedure: Baseline periodontal measurements (T0), Procedure: Periodontal measurements (T1), Procedure: Periodontal measurements (T2), Procedure: Retainer failure ratesThe fixed retainer was applied with direct bonding technique using one-step adhesive |
| Indirect bonding with conventional adhesive | Other | Procedure: Baseline periodontal measurements (T0), Procedure: Periodontal measurements (T1), Procedure: Periodontal measurements (T2), Procedure: Retainer failure ratesThe fixed retainer was applied with indirect bonding technique using two-step (conventional) adhesive |
| Indirect bonding with one-step adhesive | Other | Procedure: Baseline periodontal measurements (T0), Procedure: Periodontal measurements (T1), Procedure: Periodontal measurements (T2), Procedure: Retainer failure ratesThe fixed retainer was applied with indirect bonding technique using one-step adhesive |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Good treatment outcomes
- good oral hygiene
- No systemic or periodontal problems
- No extraction or missing anterior teeth and restorations
Key exclusion criteria (1 listed)
- Patients unwilling to wear a fixed retainer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline periodontal measurements (T0)Periodontal measurements including plaque index, gingival index and calculus index were recorded at the bonding session. | Procedure or surgery | Direct bonding with conventional adhesive, Direct bonding with one-step adhesive, Indirect bonding with conventional adhesive, Indirect bonding with one-step adhesive |
| Periodontal measurements (T1)Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 6 months after bonding. | Procedure or surgery | Direct bonding with conventional adhesive, Direct bonding with one-step adhesive, Indirect bonding with conventional adhesive, Indirect bonding with one-step adhesive |
| Periodontal measurements (T2)Periodontal measurements including plaque index, gingival index and calculus index were recorded at the 12 months after bonding. | Procedure or surgery | Direct bonding with conventional adhesive, Direct bonding with one-step adhesive, Indirect bonding with conventional adhesive, Indirect bonding with one-step adhesive |
| Retainer failure ratesA retainer with at least one composite pad detachment was considered to be a failure during 1-year follow-up. | Procedure or surgery | Direct bonding with conventional adhesive, Direct bonding with one-step adhesive, Indirect bonding with conventional adhesive, Indirect bonding with one-step adhesive |
Primary outcome
Plaque index measurements
Time frame: at the bonding session
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
Time frame: 6 months (T1) after bonding
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
Time frame: 12 months (T2) after bonding
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
Time frame: at the bonding session
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
Time frame: 6 months (T1) after bonding
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
Time frame: 12 months (T2) after bonding
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
Time frame: at bonding session
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
Time frame: 6 months after bonding
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
Time frame: 12 months after bonding
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)
1 secondary outcome
Failure rate
Time frame: during 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline periodontal measurements (T0), Periodontal measurements (T1) and Periodontal measurements (T2) in people with Periodontal Inflammation, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index measurements (time frame: at the bonding session). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.