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

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ClinicalTrials.gov Identifier: NCT02408601
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Kamineni Institute of Dental Sciences
Information provided by (Responsible Party):
Dr. Praveen B.H, Kamineni Institute of Dental Sciences

Brief 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. it is a split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite placed molars of 180 healthy school children in the age group between 7 - 10 yrs of age.

who can participate? school children in the age group between 7 - 10 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 18 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


Condition or disease Intervention/treatment Phase
Dental Caries Other: Helioseal - F Other: ART sealant Phase 2 Phase 3

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 .

Prominantly, there are basically two types of sealant materials..i.e resin based sealants which are flowable composite resins and Glass inomer 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 occulsal 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 180 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 180 subjects do have a caries free 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : March 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. retention rate as given by the simensons criteria [ Time Frame: 18 months ]
    service criteria (USPHS)


Secondary Outcome Measures :
  1. caries incidence [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408601


Locations
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India
Divya Bala School
Bhongir, Andhra Pradesh, India, 508116
Sponsors and Collaborators
Dr. Praveen B.H
Kamineni Institute of Dental Sciences
Investigators
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Principal Investigator: Praveen Haricharan Bhoopathi, M.D.S Kamineni Institute of Dental Sciences

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Responsible Party: Dr. Praveen B.H, A randomized controlled clinical trial to assess the retention and caries preventive effect of Resin based sealant versus ART sealant among the 7-10 yr old school children of a district in India. A 24 months follow up study., Kamineni Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT02408601     History of Changes
Other Study ID Numbers: KamineniIDS
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Petrolatum
Emollients
Dermatologic Agents