"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:

1. Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
2. Secondary outcomes: to evaluate, colour change and surface roughness of sealant.

Study Overview

• Status: Completed
• Conditions: PITS AND FISSURE SEALANT
• Intervention / Treatment: Drug: Sealant, Fissure

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion crieteria

1. Normal healthy children aged 7 to 10 years.
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

1. Children whose parents will not give informed consent.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

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	Drug: 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
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.	Drug: 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
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.	Drug: 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
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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate sealant retention	Alpha - complete retention Bravo- partial retention Charlie- no retention	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate marginal integrity	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	Alpha- Sound fissures. Bravo- Fissures with caries.	9 months
to evaluate colour change	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	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

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): October 3, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

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: No
• Studies a U.S. FDA-regulated device product: No