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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in India

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 groups in NCT02716558
Study groupRoleWhat they receive
Moisture tolerant resin sealantExperimentalMoisture resistant sealant (wet bond sealant)
Receives: Other: Resin sealant application
ART sealantActive comparatorGlass 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.

  1. 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.

  1. First posted23 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

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)
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

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.

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