A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants

January 4, 2021 updated by: Dr. Praveen B.H

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Bhongir, Andhra Pradesh, India, 508116
        • Divya Bala School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children belonging to high caries risk group
  • 1st permanent molars with an exaggerated pit and fissure system

Exclusion Criteria:

  • non cooperative children excluded
  • children with history of systemic diseases
  • parents haven't given their consent for this preventive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1

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
Other: Helioseal - F

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 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
Experimental: Group 2

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.
Other: ART sealant

Fuji 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
retention rate as given by the simonsons criteria
Time Frame: 24 months
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
caries incidence
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Praveen B.H

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kamineni Institute of Dental Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Praveen Haricharan Bhoopathi, M.D.S, Kamineni Institute of Dental Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KamineniIDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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