Dental CariesPhase 2/3NCT02408601
A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants
A Phase 2/3 study testing Helioseal - F and ART sealant in people with Dental Caries, run by Dr. Praveen B.H at 1 site in India.
Trial summary
Background and study aims: The investigators are carrying out a clinical trial of two different sealant materials to compare the retentivity and decay inhibiting properties of the above said materials. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Helioseal - F and ART sealant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2015to Apr 2017
- Phase
- Phase 2/3
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children belonging to high caries risk group
- 1st permanent molars with an exaggerated pit and fissure system
Who cannot join
- non cooperative children excluded
- children with history of systemic diseases
- parents haven't given their consent for this preventive therapy
Trial locations and contacts
1 site in 1 country.
About this study
Background and study aims:
The investigators are carrying out a clinical trial of two different sealant materials to compare the retentivity and decay inhibiting properties of the above said materials. it is a split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite placed molars of 198 healthy school children in the age group between 6 - 12 yrs of age.
Read more
who can participate? school children in the age group between 6 - 12 yrs of age with non decayed contra lateral permanent 1st molars at a school in the southern part of India.
what does the study involve? over a period of 24 months, the retentivity and the decay preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS) will be clinically assessed by us.
possible benefits/ risks of participating in the trial the participants will be not be exposed to any kind of risks as it is a non invasive procedure the possible benefits may be preventing decay to the permanent molar in the long run
study start date/duration of the study? MARCH 2015 is the month wherein the sealant applications have started and expected to last till the April of 2017
funding? self funded study
Read the detailed description
Pits and fissures in the first molars are the most susceptible sites for dental caries in the permanent dentition and contemporary studies show specifically that 85% or more of the caries is nested in the above-mentioned sites . Thus, prevention of caries in these tooth sites is of crucial importance in keeping a sound permanent dentition.
Sealing the pits and fissures of molars and premolars for prevention of dental caries was first introduced in the 1960s . It is now accepted as a highly effective method in preventing dental caries .
Prominently, there are basically two types of sealant materials..i.e resin based sealants which are flowable composite resins and Glass ionomer based sealants. Reading through the literature, it is well understood that the resin based sealants are more retentive than the GIC based sealants mainly because the enamel surface is etched prior to the placement and it is dispensed through syringes, thereby it generally adapts well to the surfaces. GIC sealants are known to be equally effective when to comes to caries prevention, but generally are far less retentive than the resin based sealants. the main issue regarding the placement of resin based sealants is that it is a cumbersome procedure requiring strict isolation. Looking at a dental public health point of view, especially in a country like India, the use of resin based sealants at outreach centres will be a problem because of the lack of adequate infrastructure.
To counter the limited applicability of resin based sealants in a field setting, the use of a high viscosity GIC sealant is advocated here. The high viscosity GIC sealant has a better compressive strength to take on the occlusal stress and thereby it is expected that the retention of the ART sealant (High viscous GIC sealant) using the ART technique (finger press technique) would be better than the conventional GIC based sealants. Till date, a very limited number of studies have been performed on the comparison between the ART sealant and the resin based sealant( gold standard) and thereby, this study has been conceived to assess the retentivity and the caries preventive effect of the above two systems.
The null hypothesis states that there is no expected difference between resin based sealants and ART sealants
Based on the statistical analysis, the sample size for this study has been estimated to be 198 subjects. ethical clearance has been obtained from the IRB of the dental school and informed consent obtained from all the participating subjects. This is a spilt mouth study, wherein on side, resin based sealants are placed and on the other side, the ART sealants are placed. All the participating 198 subjects do have a caries free lower permanent lower 1st right and left molars.
The sealants are placed according to the manufacturer s instructions. after placements, the retention and the caries preventive effects are followed up progressively for a period of 24 months.
- Conditions
- Dental Caries
- Being tested
- Helioseal - F, ART 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.
Helioseal - FOther
Helioseal -F ( Resin based sealant)
- isolate the tooth surface
- etch the fissure anatomy with 37% phosphoric acid for 20 seconds
- wash the tooth surface and dry it. No salivary contamination is accepeted
- using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment.
- light cure the sealant
- check for high points and the occlusion
ART sealantOther
Fuji IX extra strength
- isolate the tooth surface
- condition the fissure anatomy using a GC conditioner for 10 seconds
- wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe.
- dry the tooth surface
- mix the GIC according to the standard powder: liquid ratio
- place the mix onto the fissures using a plastic spatula
- apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly)
- apply pressure for 10-15 sec and withdraw the finger in a sideways motion
- scrap out the excess material
- check for the high points and the occlusion
- apply petroleum jelly onto the GIC mix
- advice patient not to eat or drink for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | split mouth study. one side of the arch that is the lower left permanent 1st molar will be receiving resin based sealants.
Application of the resin sealants as per the standard instructions of the manufacturer
Helioseal -F ( Resin based sealant)
1. isolate the tooth surface
2. etch the fissure anatomy with 37% phosphoric acid for 20 seconds
3. wash the tooth surface and dry it. No salivary contamination is accepted
4. using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment.
5. light cure the sealant
6. check for high points and the occlusion Receives: Other: Helioseal - F |
| Group 2 | Experimental | split mouth study. one side of the arch that is the lower right permanent 1st molar will be receiving ART sealants.
Application of the ART sealants as per the standard instructions of the manufacturer
1. isolate the tooth surface
2. condition the fissure anatomy using a GC conditioner for 10 seconds
3. wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe.
4. dry the tooth surface
5. mix the GIC according to the standard powder: liquid ratio
6. place the mix onto the fissures using a plastic spatula
7. apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly)
8. apply pressure for 10-15 sec and withdraw the finger in a sideways motion
9. scrap out the excess material
10. check for the high points and the occlusion
11. apply petroleum jelly onto the GIC mix
12. advice patient not to eat or drink for 30 minutes. Receives: Other: ART sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate as given by the simonsons criteria
Measured: 24 months
Secondary outcomes (1)
caries incidence
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 posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionApr 2017
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Praveen B.H
- Sponsor type
- University, hospital or other
- Collaborators
- Kamineni Institute of Dental Sciences
- Responsible party
- Sponsor-investigator, Dr. Praveen B.H, Kamineni Institute of Dental Sciences
- Investigators
- Praveen Haricharan Bhoopathi, M.D.S, Principal investigator, Kamineni Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408601
- Sponsor's protocol ID
- KamineniIDS
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2015
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants
- ClinicalTrials.gov ID
- NCT02408601
- Acronym / sponsor ID
- KamineniIDS
- Conditions
- Dental Caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Dr. Praveen B.HUniversity, hospital or other
- Collaborators
- Kamineni Institute of Dental Sciences
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Apr 2015 (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.
Background and study aims:
The investigators are carrying out a clinical trial of two different sealant materials to compare the retentivity and decay inhibiting properties of the above said materials. it is a split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite placed molars of 198 healthy school children in the age group between 6 - 12 yrs of age.
who can participate? school children in the age group between 6 - 12 yrs of age with non decayed contra lateral permanent 1st molars at a school in the southern part of India.
what does the study involve? over a period of 24 months, the retentivity and the decay preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS) will be clinically assessed by us.
possible benefits/ risks of participating in the trial the participants will be not be exposed to any kind of risks as it is a non invasive procedure the possible benefits may be preventing decay to the permanent molar in the long run
study start date/duration of the study? MARCH 2015 is the month wherein the sealant applications have started and expected to last till the April of 2017
funding? self funded study
Detailed description
Pits and fissures in the first molars are the most susceptible sites for dental caries in the permanent dentition and contemporary studies show specifically that 85% or more of the caries is nested in the above-mentioned sites . Thus, prevention of caries in these tooth sites is of crucial importance in keeping a sound permanent dentition.
Sealing the pits and fissures of molars and premolars for prevention of dental caries was first introduced in the 1960s . It is now accepted as a highly effective method in preventing dental caries .
Prominently, there are basically two types of sealant materials..i.e resin based sealants which are flowable composite resins and Glass ionomer based sealants. Reading through the literature, it is well understood that the resin based sealants are more retentive than the GIC based sealants mainly because the enamel surface is etched prior to the placement and it is dispensed through syringes, thereby it generally adapts well to the surfaces. GIC sealants are known to be equally effective when to comes to caries prevention, but generally are far less retentive than the resin based sealants. the main issue regarding the placement of resin based sealants is that it is a cumbersome procedure requiring strict isolation. Looking at a dental public health point of view, especially in a country like India, the use of resin based sealants at outreach centres will be a problem because of the lack of adequate infrastructure.
To counter the limited applicability of resin based sealants in a field setting, the use of a high viscosity GIC sealant is advocated here. The high viscosity GIC sealant has a better compressive strength to take on the occlusal stress and thereby it is expected that the retention of the ART sealant (High viscous GIC sealant) using the ART technique (finger press technique) would be better than the conventional GIC based sealants. Till date, a very limited number of studies have been performed on the comparison between the ART sealant and the resin based sealant( gold standard) and thereby, this study has been conceived to assess the retentivity and the caries preventive effect of the above two systems.
The null hypothesis states that there is no expected difference between resin based sealants and ART sealants
Based on the statistical analysis, the sample size for this study has been estimated to be 198 subjects. ethical clearance has been obtained from the IRB of the dental school and informed consent obtained from all the participating subjects. This is a spilt mouth study, wherein on side, resin based sealants are placed and on the other side, the ART sealants are placed. All the participating 198 subjects do have a caries free lower permanent lower 1st right and left molars.
The sealants are placed according to the manufacturer s instructions. after placements, the retention and the caries preventive effects are followed up progressively for a period of 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Helioseal - Fsplit mouth study. one side of the arch that is the lower left permanent 1st molar will be receiving resin based sealants. Application of the resin sealants as per the standard instructions of the manufacturer Helioseal -F ( Resin based sealant) 1. isolate the tooth surface 2. etch the fissure anatomy with 37% phosphoric acid for 20 seconds 3. wash the tooth surface and dry it. No salivary contamination is accepted 4. using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment. 5. light cure the sealant 6. check for high points and the occlusion |
| Group 2 | Experimental | Other: ART sealantsplit mouth study. one side of the arch that is the lower right permanent 1st molar will be receiving ART sealants. Application of the ART sealants as per the standard instructions of the manufacturer 1. isolate the tooth surface 2. condition the fissure anatomy using a GC conditioner for 10 seconds 3. wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe. 4. dry the tooth surface 5. mix the GIC according to the standard powder: liquid ratio 6. place the mix onto the fissures using a plastic spatula 7. apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly) 8. apply pressure for 10-15 sec and withdraw the finger in a sideways motion 9. scrap out the excess material 10. check for the high points and the occlusion 11. apply petroleum jelly onto the GIC mix 12. advice patient not to eat or drink for 30 minutes. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children belonging to high caries risk group
- 1st permanent molars with an exaggerated pit and fissure system
Key exclusion criteria (3 listed)
- non cooperative children excluded
- children with history of systemic diseases
- parents haven't given their consent for this preventive therapy
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 |
|---|---|---|
| Helioseal - FHelioseal -F ( Resin based sealant) 1. isolate the tooth surface 2. etch the fissure anatomy with 37% phosphoric acid for 20 seconds 3. wash the tooth surface and dry it. No salivary contamination is accepeted 4. using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment. 5. light cure the sealant 6. check for high points and the occlusion | Other | Group 1 |
| ART sealantFuji IX extra strength 1. isolate the tooth surface 2. condition the fissure anatomy using a GC conditioner for 10 seconds 3. wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe. 4. dry the tooth surface 5. mix the GIC according to the standard powder: liquid ratio 6. place the mix onto the fissures using a plastic spatula 7. apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly) 8. apply pressure for 10-15 sec and withdraw the finger in a sideways motion 9. scrap out the excess material 10. check for the high points and the occlusion 11. apply petroleum jelly onto the GIC mix 12. advice patient not to eat or drink for 30 minutes. | Other | Group 2 |
Primary outcome
retention rate as given by the simonsons criteria
Time frame: 24 months
1 secondary outcome
caries incidence
Time frame: 24 months
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 6 Jan 2021.
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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.
Praveen Haricharan Bhoopathi, M.D.S principal investigator
Kamineni Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Helioseal - F and ART sealant in people with Dental Caries, run by Dr. Praveen B.H 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 2 inclusion and 3 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 6 Jan 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 rate as given by the simonsons 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?
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 6 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.