Fissure, DentalNCT04837469
Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
A study testing fissure sealant application in people with Fissure, Dental and Adhesion, run by Ondokuz Mayıs University.
Trial summary
Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Read more about this study
- Who is it for?
- Ages 19 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure, Dental, Adhesion
- What is being tested?
- fissure sealant application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Mar 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 19 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Who cannot join
- bad oral health, maloclusion, allergy to resins used
About this study
Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Methodology: 144 sealants were placed on the permanent premolars and molars of 13 subjects. Teeth were divided into three groups SB2(control): Adper Single Bond 2, SBU-ER: Single Bond Universal/etch-and-rinse, SBU-SE: Single Bond Universal/self-etch. After the adhesive application, Fissurit FX was applied and light-cured. Clinical evaluations were done at baseline and at 1 week, 6-, 12-, 18- and 24-month recalls. Visual examination was performed on every visit for evaluation of the sealants. Evaluating criteria were: 1= completely retained; 2= partial loss; 3= total loss. The Pearson Chi-square test was used for each evaluation period.
Read the detailed description
Thirteen patients with a mean age of 20.5 (range 19-22) were selected among the patients seeking routine dental care from Conservative Dentistry Department who met the inclusion criteria. Inclusion criteria were: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Bitewing radiographs were taken. Pellicle and any remaining plaque on the fissures were removed by using slurry of pumice with a slow-speed handpiece. All restorative procedures were performed by the same operator. The teeth were assigned for different group by using a table of random numbers.
Group 1 (SB2): Etched with 35% phosphoric acid gel for 30 s, rinsed and dried. Adper Single Bond 2 (3M ESPE St. Paul MN. USA) applied and light cured for 10s with a LED device (Demi Plus; Kerr, Switzerland) Group 2 (SBU-ER) : Etched with 35% phosphoric acid gel for 30s, rinsed and dried. Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied, gently air thinned for 5 s and light cured for 10s with a LED device Group 3 (SBU-SE): Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied for 20 s with vigorous agitation, gently air thinned for 5 s and light cured for 10 s with a LED device A nanofilled fissure sealant, Fissurit FX (Voco,Cuxhaven,Germany) was applied to the fissures and air entrapment was prevented by carefull spreading with a dental probe. The sealant material was light-cured for 20 seconds with LED. The occlusion was checked with articulating paper. Fine-grit diamond burs (Diatech, Swiss Dental, Switzerland) and rubber cups (Edenta AG, AU SG, Switzerland). were used for finishing and polishing.
Each restoration was evaluated at baseline,1week after treatment and 6, 12, 18 and 24 months. Evaluation of restorations was carried out by two calibrated examiners who were unaware of group allocation and who were not involved with the treatment procedures, by the help of a mirror, blunt explorer and air stream. Caries formation was evaluated as present or absent and the sealants were evaluated according to the following criteria: 1= Completely retained 2= Partial loss 3= Total loss.
- Conditions
- Fissure, Dental, Adhesion
- Being tested
- fissure sealant application
- Keywords
- fissure sealant, adhesive
- Medical subject headings
- Dental Fissures, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fissure sealant applicationProcedure or surgery
fissure sealants were placed after differnt adhesive strategies used
| Study group | Role | What they receive |
|---|---|---|
| Universal Adhesive | Experimental | universal adhesive Receives: Procedure: fissure sealant application |
| Etch-And-Rinse Adhesive | Experimental | Etch-And-Rinse Adhesive Receives: Procedure: fissure sealant application |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of retention rate of fissure sealants
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2014
- Primary completion1 Feb 2015
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure, DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emel Karaman, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837469
- Sponsor's protocol ID
- 2014/743
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
- ClinicalTrials.gov ID
- NCT04837469
- Acronym / sponsor ID
- 2014/743
- Conditions
- Fissure, Dental, Adhesion
- Keywords
- fissure sealant, adhesive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 8 Apr 2021 (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.
Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Methodology: 144 sealants were placed on the permanent premolars and molars of 13 subjects. Teeth were divided into three groups SB2(control): Adper Single Bond 2, SBU-ER: Single Bond Universal/etch-and-rinse, SBU-SE: Single Bond Universal/self-etch. After the adhesive application, Fissurit FX was applied and light-cured. Clinical evaluations were done at baseline and at 1 week, 6-, 12-, 18- and 24-month recalls. Visual examination was performed on every visit for evaluation of the sealants. Evaluating criteria were: 1= completely retained; 2= partial loss; 3= total loss. The Pearson Chi-square test was used for each evaluation period.
Detailed description
Thirteen patients with a mean age of 20.5 (range 19-22) were selected among the patients seeking routine dental care from Conservative Dentistry Department who met the inclusion criteria. Inclusion criteria were: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Bitewing radiographs were taken. Pellicle and any remaining plaque on the fissures were removed by using slurry of pumice with a slow-speed handpiece. All restorative procedures were performed by the same operator. The teeth were assigned for different group by using a table of random numbers.
Group 1 (SB2): Etched with 35% phosphoric acid gel for 30 s, rinsed and dried. Adper Single Bond 2 (3M ESPE St. Paul MN. USA) applied and light cured for 10s with a LED device (Demi Plus; Kerr, Switzerland) Group 2 (SBU-ER) : Etched with 35% phosphoric acid gel for 30s, rinsed and dried. Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied, gently air thinned for 5 s and light cured for 10s with a LED device Group 3 (SBU-SE): Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied for 20 s with vigorous agitation, gently air thinned for 5 s and light cured for 10 s with a LED device A nanofilled fissure sealant, Fissurit FX (Voco,Cuxhaven,Germany) was applied to the fissures and air entrapment was prevented by carefull spreading with a dental probe. The sealant material was light-cured for 20 seconds with LED. The occlusion was checked with articulating paper. Fine-grit diamond burs (Diatech, Swiss Dental, Switzerland) and rubber cups (Edenta AG, AU SG, Switzerland). were used for finishing and polishing.
Each restoration was evaluated at baseline,1week after treatment and 6, 12, 18 and 24 months. Evaluation of restorations was carried out by two calibrated examiners who were unaware of group allocation and who were not involved with the treatment procedures, by the help of a mirror, blunt explorer and air stream. Caries formation was evaluated as present or absent and the sealants were evaluated according to the following criteria: 1= Completely retained 2= Partial loss 3= Total loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal Adhesive | Experimental | Procedure: fissure sealant applicationuniversal adhesive |
| Etch-And-Rinse Adhesive | Experimental | Procedure: fissure sealant applicationEtch-And-Rinse Adhesive |
Who may qualify
- Ages
- 19 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.
Key exclusion criteria (1 listed)
- bad oral health, maloclusion, allergy to resins used
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 |
|---|---|---|
| fissure sealant applicationfissure sealants were placed after differnt adhesive strategies used | Procedure or surgery | Etch-And-Rinse Adhesive, Universal Adhesive |
Primary outcome
The evaluation of retention rate of fissure sealants
Time frame: 24 month
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 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Fissure, Dental
Active, not recruiting
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Enrolling by invitation
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Molar Incisor Hypomineralization, Fissure Sealant
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
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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.
Questions about this trial
What is this clinical trial studying?
A study testing fissure sealant application in people with Fissure, Dental and Adhesion, 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 1 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 8 Apr 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?
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?
The evaluation of retention rate of fissure sealants (time frame: 24 month). 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 8 Apr 2021.