"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
NCT ID: NCT05791682
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2021-04-02
2022-11-05
Brief Summary
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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:
1. Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
2. Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Sealant, Fissure
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
NANOFILLED RESIN SEALANT
Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec.
Sealant, Fissure
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
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.
Sealant, Fissure
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
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.
Sealant, Fissure
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
Interventions
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Sealant, Fissure
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
Eligibility Criteria
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Inclusion Criteria
2. Subjects who are not undergoing any other preventive dental health treatment.
3. Availability for the duration of the study.
4. Satisfactory dental care performed at home.
5. The willingness of the patient to accept the treatment.
6. All four first permanent molars that have completely erupted with deep pits and fissures.
7. Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
Exclusion Criteria
2. Special child, a child with compromised systemic health.
3. Long-term medication affecting the salivary flow.
4. Children enrolled for other studies or fluoridation program.
5. Adverse reaction reported to any dental material.
6. Uncooperative child.
7. Bruxism or malocclusion.
8. Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS\>2).
9. Teeth with restoration and partially retained sealants.
10. Children who cannot come for the follow-up.
7 Years
10 Years
ALL
Yes
Sponsors
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Postgraduate Institute of Dental Sciences Rohtak
OTHER
Responsible Party
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Locations
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Post graduate institute of dental sciences
Rohtak, Haryana, India
Countries
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Other Identifiers
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PGIDS/BHRC/21/14
Identifier Type: -
Identifier Source: org_study_id
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