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NOT YET RECRUITING
NCT07399340
NA

A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits \& fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.

Official title: A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

6 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-03

Completion Date

2027-06

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

OTHER

Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.

1. Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013) 2. Then washing and drying the tooth with compressed air. 3. Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied on occlusal fissures in 0.5mm and brushed on preparation for 15-20sec using a micro-brush with moderate pressure. (Sabbagh et al., 2017; Sharma et al., 2018) 4. Excess material around the margins will be removed. 5. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 6. If necessary, another layer will be applied and cured for 20 seconds.

OTHER

Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.

1. Before applying Vertise Flow, surface pretreatment according to the manufacturers' recommendations for uncut enamel.(Kucukyilmaz and Savas, 2015) Using 37.5 % phosphoric acid gel Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 60 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 2. Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied in 0.5mm and brushed on fissures for 15-20sec using a micro-brush with moderate pressure.(Sabbagh et al., 2017; Sharma et al., 2018) 3. Remove excess material around the margins. 4. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 5. If necessary, another layer will be applied and cured for 20 seconds.

OTHER

Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.

1. Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013) 2. Then the occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 15-30 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 3. Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China).

OTHER

Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.

1. The occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 2. Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China )

Locations (2)

Faculty of Dentistry, Cairo University

Cairo, State/Province *, Egypt

Faculty of Dentistry, Cairo University

Cairo, State/Province *, Egypt