"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
- Conditions
- PITS AND FISSURE SEALANT
- Interventions
- Drug: Sealant, Fissure
- Registration Number
- NCT05791682
- Lead Sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NANOFILLED RESIN SEALANT Sealant, Fissure Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec. FLOWABLE COMPOSITE Sealant, Fissure 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. UNFILLED RESIN SEALANT Sealant, Fissure Unfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure. Immediately light cure for 20 sec. MICROFILLED RESIN SEALANT Sealant, Fissure -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
- Primary Outcome Measures
Name Time Method To evaluate sealant retention 9 months Alpha - complete retention Bravo- partial retention Charlie- no retention
- Secondary Outcome Measures
Name Time Method To evaluate marginal integrity 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.to evaluate anti caries effect 9 months Alpha- Sound fissures. Bravo- Fissures with caries.
to evaluate colour change 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.
to evaluate surface roughness 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.
Trial Locations
- Locations (1)
Post graduate institute of dental sciences
🇮🇳Rohtak, Haryana, India