Dental BondingNCT05340595
Effect of Primer Application on the Lingual Retainer
A study testing Orthodontic retainer bonding in people with Dental Bonding and Orthodontic Retainers, run by Ondokuz Mayıs University.
Trial summary
Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months. Read more about this study
- Who is it for?
- Ages 11 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Bonding, Orthodontic Retainers
- What is being tested?
- Orthodontic retainer bonding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2014to 23 Jul 2016
- 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 11 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Individuals who will continue to the retention phase after fixed orthodontic treatment,
- Presence of all mandibular incisor and canine teeth,
- Good oral hygiene,
- No caries,
- No fractures,
- Healthy periodontal condition,
Show all 9Show fewer
- No restorations,
- No previous bonded retainer,
- No traumatic parafunctional habits such as bruxism.
Who cannot join
- -
About this study
Official title: Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer
Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.
Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.
The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P < 0.05.
- Conditions
- Dental Bonding, Orthodontic Retainers
- Being tested
- Orthodontic retainer bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic retainer bondingOther
Self-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The primer (Transbond XT Primer; 3M Unitek, California) was applied in a thin and uniform coat. Then the adhesive resin (Transbond LR Light Cure Adhesive Paste; 3M Unitek, California) was administered to the lingual surface of the anterior teeth and the lingual retainer was placed in position. The adhesive resin was polymerized from two directions for a total of 20 s using a visible-light curing unit (Hilux 200, Benlioglu Dental Inc., Ankara, Turkey) with an output power of 600 mW/cm2. Receives: Other: Orthodontic retainer bonding |
| Study group | Active comparator | In the study group, the SEP (3M Unitek, Monrovia, California) was used according to the manufacturer's instructions, namely it was administered to the lingual surfaces of the teeth and rubbed for 3 s. Then a gentle burst of dry air was delivered to thin the primer. In the control group, the lingual surfaces of the teeth were etched using 37% phosphoric etchant liquid gel (3M Espe, St Paul, Minnesota, USA) for 30 s, followed by rinsing and drying. Receives: Other: Orthodontic retainer bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bond Failure Rate of a Mandibular Bonded Lingual Retainer
Bond Failure Rate of a Mandibular Bonded Lingual Retainer
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start2 Mar 2014
- Primary completion2 Nov 2015
- Study completion23 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental BondingStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- Sabahat Yazıcıoğlu
- Responsible party
- Principal investigator, Dr. Fethiye ÇAKMAK ÖZLÜ, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340595
- Sponsor's protocol ID
- 2013/17
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elekdag-Turk S, Isci D, Turk T, Cakmak F. Six-month bracket failure rate evaluation of a self-etching primer. Eur J Orthod. 2008 Apr;30(2):211-6. doi: 10.1093/ejo/cjm119. Epub 2008 Jan 23.
PubMed 18216373Sfondrini MF, Cacciafesta V, Scribante A, De Angelis M, Klersy C. Effect of blood contamination on shear bond strength of brackets bonded with conventional and self-etching primers. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):357-60. doi: 10.1016/j.ajodo.2003.09.022.
PubMed 15014415
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Etch Primer Application on the Bond Failure Rate of a Mandibular Bonded Lingual Retainer
- ClinicalTrials.gov ID
- NCT05340595
- Acronym / sponsor ID
- 2013/17
- Conditions
- Dental Bonding, Orthodontic Retainers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- Sabahat Yazıcıoğlu
- Study start
- 2 Mar 2014 (actual)
- Primary completion
- 2 Nov 2015 (actual)
- Study completion
- 23 Jul 2016 (actual)
- First posted
- 22 Apr 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.
Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.
Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.
The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Orthodontic retainer bondingThe primer (Transbond XT Primer; 3M Unitek, California) was applied in a thin and uniform coat. Then the adhesive resin (Transbond LR Light Cure Adhesive Paste; 3M Unitek, California) was administered to the lingual surface of the anterior teeth and the lingual retainer was placed in position. The adhesive resin was polymerized from two directions for a total of 20 s using a visible-light curing unit (Hilux 200, Benlioglu Dental Inc., Ankara, Turkey) with an output power of 600 mW/cm2. |
| Study group | Active comparator | Other: Orthodontic retainer bondingIn the study group, the SEP (3M Unitek, Monrovia, California) was used according to the manufacturer's instructions, namely it was administered to the lingual surfaces of the teeth and rubbed for 3 s. Then a gentle burst of dry air was delivered to thin the primer. In the control group, the lingual surfaces of the teeth were etched using 37% phosphoric etchant liquid gel (3M Espe, St Paul, Minnesota, USA) for 30 s, followed by rinsing and drying. |
Who may qualify
- Ages
- 11 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Individuals who will continue to the retention phase after fixed orthodontic treatment,
- Presence of all mandibular incisor and canine teeth,
- Good oral hygiene,
- No caries,
- No fractures,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Orthodontic retainer bondingSelf-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces. | Other | Control group, Study group |
Primary outcome
Bond Failure Rate of a Mandibular Bonded Lingual Retainer
Time frame: 24 months
Bond Failure Rate of a Mandibular Bonded Lingual Retainer
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 28 Apr 2022.
- Background: PubMed 18216373Elekdag-Turk S, Isci D, Turk T, Cakmak F. Six-month bracket failure rate evaluation of a self-etching primer. Eur J Orthod. 2008 Apr;30(2):211-6. doi: 10.1093/ejo/cjm119. Epub 2008 Jan 23.
- Background: PubMed 15014415Sfondrini MF, Cacciafesta V, Scribante A, De Angelis M, Klersy C. Effect of blood contamination on shear bond strength of brackets bonded with conventional and self-etching primers. Am J Orthod Dentofacial Orthop. 2004 Mar;125(3):357-60. doi: 10.1016/j.ajodo.2003.09.022.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Bonding
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Comparison of Orthodontic Bracket Bond Failure Using Acid Etching With or Without Sandblasting
Dental Etching, Dental Bonding
Recruiting
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Animal-Human Bonding, Dental Anxiety
Recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
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.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic retainer bonding in people with Dental Bonding and Orthodontic Retainers, run by Ondokuz Mayıs University.
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 9 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Bond Failure Rate of a Mandibular Bonded Lingual Retainer (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05340595, which also lists 2 linked publications.
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 28 Apr 2022; AzTrials last refreshed its copy on 3 Nov 2026.