RetentionPhase 3NCT02716558
A Clinical Trial to Assess the Retention and Caries Preventive Effects of Moisture Tolerant Resin Sealant and ART Sealants
A Phase 3 study testing ART Sealant Application and Resin sealant application in people with Retention, run by Dr. Praveen B.H at 1 site in India.
Trial summary
It is a clinical trial which employs a split mouth design to assess the retention of a moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants on a representative sample of 7- 12 year old school children of a district in Belgaum, Karnataka, India. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- ART Sealant Application and Resin sealant application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2016to Apr 2017
- Phase
- Phase 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects with fully erupted contralateral permanent mandibular first molars with well defined deep irregular pits and fissures. The entire tooth surface should be visible in the mouth and free of mucosal tissue.
Who cannot join
- An open carious lesion exists.
- A large occlusal restoration if already present.
- Presence of caries on the other surfaces of the same tooth.
- Subjects with developmental anomalies and hypoplastic permanent first molars.
- Subjects who were suffering from any systemic disease or those who were on any long term medication.
Trial locations and contacts
1 site in 1 country.
India1 site
Maratha Mandal's Nathajirao G. Halgekar Institute of Dental Sciences & Research Centre.
Belagavi, Karnataka, 590010
About this study
It is a clinical trial which employs a split mouth design to assess the retention of a moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants on a representative sample of 7- 12 year old school children of a district in Belgaum, Karnataka, India.
Read the detailed description
Dental caries is a diet dependent, transmissible, micro biologically mediated disease, which follows both an infectious and chronic disease model that progresses slowly with periods of quiescence.
From the literature available, it is understood that although dental caries is on the decline in many of the developed countries, it still remains unchanged with regards to pits and fissure caries of occlusal surfaces of the teeth. This increase in susceptibility is due to its inherent morphological structure which makes a person unable to maintain cleanliness devoid of food lodgement.. Although pits and fissures of occlusal surfaces form only 12.5% of all tooth surfaces yet, they constitute more than 2/3rd of total caries experience among young permanent teeth.
The prevention of dental caries not only includes measures to prevent the occurrence of disease, such as risk factor reduction, but also to arrest the progress of disease and reduce the consequences of disease once it is established Creativity in this effort against fissure caries continues, with newer materials and technology tested each year. The traditional preventive methods, such as diet control and fluoride therapy effectively prevent dental caries on smooth tooth surfaces, but they have not been satisfactory methods to control caries in pit and fissures.
At the time that acid etch bonding was first described by Buonocore in 1955 , bonding was a new technology, and a logical step in its use was the prevention of pit and fissure decay. The focus of Buonocore's work was the development of a sealant to prevent occlusal caries on posterior teeth.Thus, resin sealants were born. Acid treatment of enamel or dentin, whether a priory or concomitant bonding step, has been integrated into methods to retain materials and significantly reduce micro leakage at material tooth interfaces.
Pit and fissure sealant is a "cement or resin material which is introduced into unprepared occlusal pit and fissure of caries susceptible teeth, forming a mechanical and physical protective layer against the action of acid producing bacteria and their substrate".
Pit and fissure sealants introduced by Cueto and Buonocore in 1967 have been accepted as an efficient caries preventive method. For most of the period since the introduction of the sealants, the focus has been on Bis-GMA resin based materials. Resin based sealants have been tested on many occasions and have generally been shown to be an effective method of caries prevention for children and young adults,. The efficacy of these resin sealants in preventing caries has been associated with the duration and degree of sealant retention.
However, the application of resin based sealants demands total moisture control as they are hydrophobic in nature and is often only possible to a limited extent particularly in children with low compliance. Ideally, a material combining the attributes of resin based sealants, such as good retention and good physical properties with moisture tolerance would be desirable.
Recently, a unique moisture tolerant resin based sealant called the embrace wet bond sealant has been introduced. Embrace incorporates di-tri and multi-functional acrylate monomers into an advanced acid integrating chemistry that is activated by moisture. The advantages are wet bonding, tooth integrating, better retention, superior marginal seal, less technique sensitive and increased fluoride release.
Another class of sealants that have been developed are the glass inomer based sealants and these are primarily indicated for subjects, where in total moisture control is not achievable. These sealants, although being hydrophilic have a major drawback which is the low retentivity. In order to overcome this drawback, high viscosity glass inomer cements using the ART approach have been introduced as sealant materials.
A notable point which has been to be given further consideration is the fact that although the embrace wet bond sealant (resin based sealant) and the ART sealant (GIC based sealant) belong to different classes of sealants, they can be indicated in conditions where total moisture control is impossible to achieve.
There is an absolute lack of information regarding the relative performance of the moisture tolerant resin based sealant (embrace wet bond sealant) against the ART sealants and therefore this clinical trial will evaluate the retention and the caries preventive aspect of the above said materials among a representative sample of 7- 10 year old caries prone children.
- Conditions
- Retention
- Being tested
- ART Sealant Application, Resin sealant application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART Sealant ApplicationOther
application of the ART sealant using high viscosity glass inomer cements.
Resin sealant applicationOther
application of the moisture tolerant sealant according to the manufacturers instructions.
| Study group | Role | What they receive |
|---|---|---|
| Moisture tolerant resin sealant | Experimental | Moisture resistant sealant (wet bond sealant) Receives: Other: Resin sealant application |
| ART sealant | Active comparator | Glass inomer based sealant Receives: Other: ART Sealant Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the sealants
The retention of the sealants will be assessed by using the MODIFIED SIMENSONS CRITERIA
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 posted23 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2017
- Study completionApr 2017
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 RetentionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Praveen B.H
- Sponsor type
- University, hospital or other
- Collaborators
- Nathajirao G. Halgekar Institute of Dental Sciences & Research centre, Karnataka, India
- Responsible party
- Sponsor-investigator, Dr. Praveen B.H, Kamineni Institute of Dental Sciences
- Investigators
- Praveen Bhoopathi, M.D.S, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716558
- Sponsor's protocol ID
- AIMST university
- Status last verified
- Jun 2018
- First submitted
- 7 Mar 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Haricharan PB, Barad N, Patil CR, Voruganti S, Mudrakola DP, Turagam N. Dawn of a New Age Fissure Sealant? A Study Evaluating the Clinical Performance of Embrace WetBond and ART Sealants: Results from a Randomized Controlled Clinical Trial. Eur J Dent. 2019 Oct;13(4):503-509. doi: 10.1055/s-0039-1696894. Epub 2019 Dec 31.
PubMed 31891967
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. 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 Effects of Moisture Tolerant Resin Sealant and ART Sealants
- ClinicalTrials.gov ID
- NCT02716558
- Acronym / sponsor ID
- AIMST university
- Conditions
- Retention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dr. Praveen B.HUniversity, hospital or other
- Collaborators
- Nathajirao G. Halgekar Institute of Dental Sciences & Research centre, Karnataka, India
- Study start
- Feb 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Mar 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.
It is a clinical trial which employs a split mouth design to assess the retention of a moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants on a representative sample of 7- 12 year old school children of a district in Belgaum, Karnataka, India.
Detailed description
Dental caries is a diet dependent, transmissible, micro biologically mediated disease, which follows both an infectious and chronic disease model that progresses slowly with periods of quiescence.
From the literature available, it is understood that although dental caries is on the decline in many of the developed countries, it still remains unchanged with regards to pits and fissure caries of occlusal surfaces of the teeth. This increase in susceptibility is due to its inherent morphological structure which makes a person unable to maintain cleanliness devoid of food lodgement.. Although pits and fissures of occlusal surfaces form only 12.5% of all tooth surfaces yet, they constitute more than 2/3rd of total caries experience among young permanent teeth.
The prevention of dental caries not only includes measures to prevent the occurrence of disease, such as risk factor reduction, but also to arrest the progress of disease and reduce the consequences of disease once it is established Creativity in this effort against fissure caries continues, with newer materials and technology tested each year. The traditional preventive methods, such as diet control and fluoride therapy effectively prevent dental caries on smooth tooth surfaces, but they have not been satisfactory methods to control caries in pit and fissures.
At the time that acid etch bonding was first described by Buonocore in 1955 , bonding was a new technology, and a logical step in its use was the prevention of pit and fissure decay. The focus of Buonocore's work was the development of a sealant to prevent occlusal caries on posterior teeth.Thus, resin sealants were born. Acid treatment of enamel or dentin, whether a priory or concomitant bonding step, has been integrated into methods to retain materials and significantly reduce micro leakage at material tooth interfaces.
Pit and fissure sealant is a "cement or resin material which is introduced into unprepared occlusal pit and fissure of caries susceptible teeth, forming a mechanical and physical protective layer against the action of acid producing bacteria and their substrate".
Pit and fissure sealants introduced by Cueto and Buonocore in 1967 have been accepted as an efficient caries preventive method. For most of the period since the introduction of the sealants, the focus has been on Bis-GMA resin based materials. Resin based sealants have been tested on many occasions and have generally been shown to be an effective method of caries prevention for children and young adults,. The efficacy of these resin sealants in preventing caries has been associated with the duration and degree of sealant retention.
However, the application of resin based sealants demands total moisture control as they are hydrophobic in nature and is often only possible to a limited extent particularly in children with low compliance. Ideally, a material combining the attributes of resin based sealants, such as good retention and good physical properties with moisture tolerance would be desirable.
Recently, a unique moisture tolerant resin based sealant called the embrace wet bond sealant has been introduced. Embrace incorporates di-tri and multi-functional acrylate monomers into an advanced acid integrating chemistry that is activated by moisture. The advantages are wet bonding, tooth integrating, better retention, superior marginal seal, less technique sensitive and increased fluoride release.
Another class of sealants that have been developed are the glass inomer based sealants and these are primarily indicated for subjects, where in total moisture control is not achievable. These sealants, although being hydrophilic have a major drawback which is the low retentivity. In order to overcome this drawback, high viscosity glass inomer cements using the ART approach have been introduced as sealant materials.
A notable point which has been to be given further consideration is the fact that although the embrace wet bond sealant (resin based sealant) and the ART sealant (GIC based sealant) belong to different classes of sealants, they can be indicated in conditions where total moisture control is impossible to achieve.
There is an absolute lack of information regarding the relative performance of the moisture tolerant resin based sealant (embrace wet bond sealant) against the ART sealants and therefore this clinical trial will evaluate the retention and the caries preventive aspect of the above said materials among a representative sample of 7- 10 year old caries prone children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moisture tolerant resin sealant | Experimental | Other: Resin sealant applicationMoisture resistant sealant (wet bond sealant) |
| ART sealant | Active comparator | Other: ART Sealant ApplicationGlass inomer based sealant |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects with fully erupted contralateral permanent mandibular first molars with well defined deep irregular pits and fissures. The entire tooth surface should be visible in the mouth and free of mucosal tissue.
Key exclusion criteria (5 listed)
- An open carious lesion exists.
- A large occlusal restoration if already present.
- Presence of caries on the other surfaces of the same tooth.
- Subjects with developmental anomalies and hypoplastic permanent first molars.
- Subjects who were suffering from any systemic disease or those who were on any long term medication.
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 |
|---|---|---|
| ART Sealant Applicationapplication of the ART sealant using high viscosity glass inomer cements. | Other | ART sealant |
| Resin sealant applicationapplication of the moisture tolerant sealant according to the manufacturers instructions. | Other | Moisture tolerant resin sealant |
Primary outcome
Retention of the sealants
Time frame: Baseline to 1 year
The retention of the sealants will be assessed by using the MODIFIED SIMENSONS CRITERIA
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 26 Jun 2018.
- Derived from this study: PubMed 31891967Haricharan PB, Barad N, Patil CR, Voruganti S, Mudrakola DP, Turagam N. Dawn of a New Age Fissure Sealant? A Study Evaluating the Clinical Performance of Embrace WetBond and ART Sealants: Results from a Randomized Controlled Clinical Trial. Eur J Dent. 2019 Oct;13(4):503-509. doi: 10.1055/s-0039-1696894. Epub 2019 Dec 31.
- 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.
Praveen Bhoopathi, M.D.S study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ART Sealant Application and Resin sealant application in people with Retention, 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 1 inclusion and 5 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 26 Jun 2018. 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 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 of the sealants (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?
On the ClinicalTrials.gov record for NCT02716558, 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 26 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.