Dental CariesPhase 4NCT02795728
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
A Phase 4 study testing Application of the GIC based sealant and Resin based sealant in people with Dental Caries, run by Kamineni Institute of Dental Sciences at 1 site in India.
Trial summary
Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light… Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Application of the GIC based sealant and Resin based sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 4
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.
Who cannot join
- Molars with developmental anomalies, hypoplastic teeth were promptly excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.
- Conditions
- Dental Caries
- Being tested
- Application of the GIC based sealant, Resin based sealant
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the GIC based sealantOther
Application of the GIC based sealant was carried out according to the manufacturer's instructions.
Resin based sealantOther
Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Fuji type VII is a GIC based sealant with an additional property of high fluoride release Receives: Other: Application of the GIC based sealant |
| Resin based sealant | Active comparator | Helioseal F is a resin based sealant Receives: Other: Resin based sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the sealant
Retention of the sealants will be assessed by using the Simensons criteria
Measured: Baseline to 1 year
Secondary outcomes (1)
Caries incidence
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamineni Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Praveen B.H, Kamineni Institute of Dental Sciences
- Investigators
- Prathibha Rao, MDS, Study director, Sri Sai college of Dental surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795728
- Sponsor's protocol ID
- SSCDS
- Status last verified
- May 2016
- First submitted
- 28 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
- ClinicalTrials.gov ID
- NCT02795728
- Acronym / sponsor ID
- SSCDS
- Conditions
- Dental Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kamineni Institute of Dental SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jun 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.
Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Application of the GIC based sealantFuji type VII is a GIC based sealant with an additional property of high fluoride release |
| Resin based sealant | Active comparator | Other: Resin based sealantHelioseal F is a resin based sealant |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.
Key exclusion criteria (1 listed)
- Molars with developmental anomalies, hypoplastic teeth were promptly excluded
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 |
|---|---|---|
| Application of the GIC based sealantApplication of the GIC based sealant was carried out according to the manufacturer's instructions. | Other | Experimental arm |
| Resin based sealantApplication of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations. | Other | Resin based sealant |
Primary outcome
Retention of the sealant
Time frame: Baseline to 1 year
Retention of the sealants will be assessed by using the Simensons criteria
1 secondary outcome
Caries incidence
Time frame: Baseline to 1 year
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 10 Jun 2016.
- Individual participant dataSharing planned: Yes
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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.
Prathibha Rao, MDS study director
Sri Sai college of Dental surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Application of the GIC based sealant and Resin based sealant in people with Dental Caries, run by Kamineni Institute of Dental Sciences at 1 site in India.
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 10 Jun 2016. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of the sealant (time frame: Baseline to 1 year). 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 10 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.