Fuji Type VII Sealant Versus Resin Based Sealant. A Clini... | NCT02795728

Studies
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial

NCT02795728

Sponsor

Kamineni Institute of Dental Sciences

Status

Completed

Last Update Posted

Jun 10, 2016Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Dental Caries

Interventions

Application of the GIC based sealant
Resin based sealant

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

May 28, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2016

Last Update Posted Date

Jun 10, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Praveen B.H, Assistant Professor, Kamineni Institute of Dental SciencesPrincipal Investigator

Lead Sponsor

Kamineni Institute of Dental SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental arm	Experimental	Fuji type VII is a GIC based sealant with an additional property of high fluoride release	Other: Application of the GIC based sealant
Resin based sealant	Active Comparator	Helioseal F is a resin based sealant	Other: Resin based sealant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Application of the GIC based sealant	Other	Application of the GIC based sealant was carried out according to the manufacturer's instructions.	Experimental arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retention of the sealant	Retention of the sealants will be assessed by using the Simensons criteria	Baseline to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Caries incidence		Baseline to 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.

Exclusion Criteria:

Molars with developmental anomalies, hypoplastic teeth were promptly excluded

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prathibha Rao, MDS	Sri Sai college of Dental surgery	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sri Sai college of Dental surgery		Vikārābād	Telangana	501101	India

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided