Fissure SealantNCT03718689
Effect of Er:YAG Laser on Hydrophilic Sealants
A study testing Laser etching in people with Fissure Sealant, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant
- What is being tested?
- Laser etching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 15 Oct 2018
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who participated in this study had good general health and oral hygiene.
- Fully erupted permanent first molar teeth with deep, narrow fissures
- Teeth with no detectable occlusal and proximal caries
Who cannot join
- Hypomineralized areas such as fluorosis, molar incisor hypomineralization
- Allergy to resins, who were not willing to participate in the study.
- Teeth with hypomineralized areas such as fluorosis,
- Teeth with molar incisor hypomineralization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Er:YAG Laser on Clinical Success of a Hydrophilic Fissure Sealant
This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry. The patients involved in the study were aged between 7-11 years who had fully erupted permanent first molars, which were suitable for non-invasive fissure sealant application (narrow, deep fissures).
Read the detailed description
The permanent first molar teeth were cleaned using a polishing brush and pumice and isolated with cotton rolls. Caries status was assessed using DIAGNOdent pen (DIAGNOdent pen 2190, KaVo, Biberach, Germany) at the occlusal and proximal sites. Teeth having DIAGNOdent readings of 12 or less at the occlusal site and 7 or less at the proximal site were included in the study. Then, the teeth were divided into three groups. The first group (Grup A) of teeth were etched with phosphoric acid, the second group of teeth (Group L) were etched with Er:YAG laser and the third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. The patients were recalled for follow up examination at the 3rd, 6th and 9th months. The teeth were assessed using mouth mirror and explorer regarding new caries formation and retention of the fissure sealants. The obtained data were analyzed using SPSS 24.0 (SPSS 24.0 for Windows, SPSS Inc., Chicago, IL, USA).
- Conditions
- Fissure Sealant
- Being tested
- Laser etching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser etchingDevice
Also called Acid
Acid etching
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | The second group of teeth (Group L) were etched with Er:YAG laser. Receives: Device: Laser etching |
| Group A+L | Experimental | The third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. Receives: Device: Laser etching |
| Group A | No intervention | The first group of teeth (Group A) were not etched with Er:YAG laser. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
Clinical success
Measured: Change from Baseline retention rate at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jan 2018
- Primary completion30 Sep 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fissure SealantStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan KELES, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718689
- Sponsor's protocol ID
- 2018-048
- Status last verified
- Feb 2020
- First submitted
- 22 Oct 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be shared with other researchers.
Publications
Guclu ZA, Hurt AP, Donmez N, Coleman NJ. Effect of Er:YAG laser enamel conditioning and moisture on the microleakage of a hydrophilic sealant. Odontology. 2018 Jul;106(3):225-231. doi: 10.1007/s10266-017-0323-4. Epub 2017 Dec 13.
PubMed 29236177
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Er:YAG Laser on Clinical Success of a Hydrophilic Fissure Sealant
- ClinicalTrials.gov ID
- NCT03718689
- Acronym / sponsor ID
- 2018-048
- Conditions
- Fissure Sealant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 24 Oct 2018 (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.
This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry. The patients involved in the study were aged between 7-11 years who had fully erupted permanent first molars, which were suitable for non-invasive fissure sealant application (narrow, deep fissures).
Detailed description
The permanent first molar teeth were cleaned using a polishing brush and pumice and isolated with cotton rolls. Caries status was assessed using DIAGNOdent pen (DIAGNOdent pen 2190, KaVo, Biberach, Germany) at the occlusal and proximal sites. Teeth having DIAGNOdent readings of 12 or less at the occlusal site and 7 or less at the proximal site were included in the study. Then, the teeth were divided into three groups. The first group (Grup A) of teeth were etched with phosphoric acid, the second group of teeth (Group L) were etched with Er:YAG laser and the third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. The patients were recalled for follow up examination at the 3rd, 6th and 9th months. The teeth were assessed using mouth mirror and explorer regarding new caries formation and retention of the fissure sealants. The obtained data were analyzed using SPSS 24.0 (SPSS 24.0 for Windows, SPSS Inc., Chicago, IL, USA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Device: Laser etchingThe second group of teeth (Group L) were etched with Er:YAG laser. |
| Group A+L | Experimental | Device: Laser etchingThe third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. |
| Group A | No intervention | –The first group of teeth (Group A) were not etched with Er:YAG laser. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who participated in this study had good general health and oral hygiene.
- Fully erupted permanent first molar teeth with deep, narrow fissures
- Teeth with no detectable occlusal and proximal caries
Key exclusion criteria (4 listed)
- Hypomineralized areas such as fluorosis, molar incisor hypomineralization
- Allergy to resins, who were not willing to participate in the study.
- Teeth with hypomineralized areas such as fluorosis,
- Teeth with molar incisor hypomineralization
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 |
|---|---|---|
| Laser etchingAlso: AcidAcid etching | Device | Group A+L, Group L |
Primary outcome
Retention rate
Time frame: Change from Baseline retention rate at 12 months
Clinical success
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 17 Feb 2020.
- Results publication: PubMed 29236177Guclu ZA, Hurt AP, Donmez N, Coleman NJ. Effect of Er:YAG laser enamel conditioning and moisture on the microleakage of a hydrophilic sealant. Odontology. 2018 Jul;106(3):225-231. doi: 10.1007/s10266-017-0323-4. Epub 2017 Dec 13.
- Individual participant dataSharing planned: Undecided. The results will be shared with other researchers.
Related trials for Fissure Sealant
Active, not recruiting
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Dental Caries, Fissure Sealant
Enrolling by invitation
Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH).
Molar Incisor Hypomineralization, Fissure Sealant
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
RecruitingPhase 1
COES: Curing Order Effects on Sealants
Dental Sealant, Sealant Retention
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
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 Laser etching in people with Fissure Sealant, run by Aydin Adnan Menderes 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 3 inclusion and 4 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 17 Feb 2020. 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?
Retention rate (time frame: Change from Baseline retention rate at 12 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 NCT03718689, which also lists 1 linked publication.
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 17 Feb 2020.