Dental Caries on Pit and Fissure SurfaceNCT02897089
Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives
A study testing Adhesive agent in people with Dental Caries on Pit and Fissure Surface, run by Hacettepe University.
Trial summary
The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries on Pit and Fissure Surface
- What is being tested?
- Adhesive agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2022to 30 Mar 2025
- 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teeth having clinical indication of sealing with pit and fissure sealant.
- Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures.
Who cannot join
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents
The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.
Read the detailed description
Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant.
Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant
Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated.
The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.
- Conditions
- Dental Caries on Pit and Fissure Surface
- Being tested
- Adhesive agent
- Keywords
- universal adhesive, fissure sealants, retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive agentDevice
Agents used to bond the restorative materials to teeth structure.
| Study group | Role | What they receive |
|---|---|---|
| acid-etch | No intervention | Acid etch+fissure sealant |
| All Bond universal adhesive | Other | Acid etch+ All Bond universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| All Bond universal | Other | All Bond universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| Scotchbond universal adhesive | Other | Acid etch+ Scotchbond universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| Scotchbond universal | Other | Scotchbond universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| Clearfil universal adhesive | Other | Acid etch+ Clearfil universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| Clearfil universal | Other | Clearfil universal adhesive agent+fissure sealant Receives: Device: Adhesive agent |
| Total-etch Dental Adhesive | Other | Acid etch+ Single Bond adhesive agent+fissure sealant Receives: Device: Adhesive agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria
Long-term clinical success of different universal adhesives under fissure sealants
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 posted13 Sep 2016 (estimated)
- Study start31 Mar 2022 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental Caries on Pit and Fissure SurfaceStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer C Cehreli, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897089
- Sponsor's protocol ID
- HUDHF-1
- Status last verified
- Mar 2021
- First submitted
- 25 Aug 2016
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McCafferty J, O'Connell AC. A randomised clinical trial on the use of intermediate bonding on the retention of fissure sealants in children. Int J Paediatr Dent. 2016 Mar;26(2):110-5. doi: 10.1111/ipd.12165. Epub 2015 Apr 10.
PubMed 25864681Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.
PubMed 11145354Karaman E, Yazici AR, Tuncer D, Firat E, Unluer S, Baseren M. A 48-month clinical evaluation of fissure sealants placed with different adhesive systems. Oper Dent. 2013 Jul-Aug;38(4):369-75. doi: 10.2341/12-181-C. Epub 2012 Dec 4.
PubMed 23210859
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents
- ClinicalTrials.gov ID
- NCT02897089
- Acronym / sponsor ID
- HUDHF-1
- Conditions
- Dental Caries on Pit and Fissure Surface
- Keywords
- universal adhesive, fissure sealants, retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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 purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.
Detailed description
Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant.
Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant
Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated.
The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| acid-etch | No intervention | –Acid etch+fissure sealant |
| All Bond universal adhesive | Other | Device: Adhesive agentAcid etch+ All Bond universal adhesive agent+fissure sealant |
| All Bond universal | Other | Device: Adhesive agentAll Bond universal adhesive agent+fissure sealant |
| Scotchbond universal adhesive | Other | Device: Adhesive agentAcid etch+ Scotchbond universal adhesive agent+fissure sealant |
| Scotchbond universal | Other | Device: Adhesive agentScotchbond universal adhesive agent+fissure sealant |
| Clearfil universal adhesive | Other | Device: Adhesive agentAcid etch+ Clearfil universal adhesive agent+fissure sealant |
| Clearfil universal | Other | Device: Adhesive agentClearfil universal adhesive agent+fissure sealant |
| Total-etch Dental Adhesive | Other | Device: Adhesive agentAcid etch+ Single Bond adhesive agent+fissure sealant |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Teeth having clinical indication of sealing with pit and fissure sealant.
- Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures.
Key exclusion criteria (2 listed)
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
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 |
|---|---|---|
| Adhesive agentAgents used to bond the restorative materials to teeth structure. | Device | All Bond universal, All Bond universal adhesive, Clearfil universal, Clearfil universal adhesive, Scotchbond universal, Scotchbond universal adhesive, Total-etch Dental Adhesive |
Primary outcome
Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria
Time frame: 24 months
Long-term clinical success of different universal adhesives under fissure sealants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 25864681McCafferty J, O'Connell AC. A randomised clinical trial on the use of intermediate bonding on the retention of fissure sealants in children. Int J Paediatr Dent. 2016 Mar;26(2):110-5. doi: 10.1111/ipd.12165. Epub 2015 Apr 10.
- Background: PubMed 11145354Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601.
- Background: PubMed 23210859Karaman E, Yazici AR, Tuncer D, Firat E, Unluer S, Baseren M. A 48-month clinical evaluation of fissure sealants placed with different adhesive systems. Oper Dent. 2013 Jul-Aug;38(4):369-75. doi: 10.2341/12-181-C. Epub 2012 Dec 4.
- Individual participant dataSharing planned: Undecided
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.
Zafer C Cehreli, Prof principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive agent in people with Dental Caries on Pit and Fissure Surface, run by Hacettepe 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zafer C Cehreli, Prof (00903123052280, zcehreli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria (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 NCT02897089, which also lists 3 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 15 Mar 2021.