- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05791682
"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
"Comparative Clinical Evaluation of Microfilled Resin Sealant, Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children."
Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups.
Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial.
Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group.
Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows:
Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit.
OUTCOME MEASURES:
- Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
- Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post Graduate Institute of Dental Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion crieteria
- Normal healthy children aged 7 to 10 years.
- Subjects who are not undergoing any other preventive dental health treatment.
- Availability for the duration of the study.
- Satisfactory dental care performed at home.
- The willingness of the patient to accept the treatment.
- All four first permanent molars that have completely erupted with deep pits and fissures.
- Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
EXCLUSION CRITERIA
- Children whose parents will not give informed consent.
- Special child, a child with compromised systemic health.
- Long-term medication affecting the salivary flow.
- Children enrolled for other studies or fluoridation program.
- Adverse reaction reported to any dental material.
- Uncooperative child.
- Bruxism or malocclusion.
- Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
- Teeth with restoration and partially retained sealants.
- Children who cannot come for the follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MICROFILLED RESIN SEALANT
-Microfilled rein sealant (fissurit FX) after etching, washing, drying, sealant was gradually applied along the fissure of first permanent molar, Immediately light cured for 20 sec
|
FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
|
Active Comparator: NANOFILLED RESIN SEALANT
Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure.
Immediately light cured for 20 sec.
|
FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
|
Active Comparator: FLOWABLE COMPOSITE
Flowable composite (Te-Econom Flow) after etching, washing, drying, adhesive was applied and dried under gentle air flow for 2-3 sec and was light cured.
A uniform layer of flowable composite was applied and light cure for 20 sec.
|
FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
|
Active Comparator: UNFILLED RESIN SEALANT
Unfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure.
Immediately light cure for 20 sec.
|
FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate sealant retention
Time Frame: 9 months
|
Alpha - complete retention Bravo- partial retention Charlie- no retention
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate marginal integrity
Time Frame: 9 months
|
Alpha- No visible evidence of a crevice along the margin of the sealant that the explorer could penetrate. Bravo- Visible evidence of a crevice along the margin of the sealant that the explorer could penetrate. |
9 months
|
to evaluate anti caries effect
Time Frame: 9 months
|
Alpha- Sound fissures.
Bravo- Fissures with caries.
|
9 months
|
to evaluate colour change
Time Frame: 9 months
|
Alpha- No discoloration anywhere on the margin around the sealant.
Bravo- Visible partial discoloration the margin around sealant.
Charlie- Visible discoloration on the margin around all sealant.
|
9 months
|
to evaluate surface roughness
Time Frame: 9 months
|
Alpha- The sealant is similar to polished enamel. Bravo- The sealant surface is similar to composite material surface contained submicron filler. Charlie- The surface is rough that prevents the explorer movement along the surface. |
9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PGIDS/BHRC/21/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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