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| Name | Class |
|---|---|
| National Research Centre, Egypt | OTHER |
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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.
This randomized controlled clinical trial aims to compare the retention and clinical performance of a self-adhering flowable composite and a conventional resin-based pit and fissure sealant, applied with and without fissurotomy, in newly erupted permanent first molars of children aged 6-8 years.
Occlusal pits and fissures are highly susceptible to dental caries in children, and long-term sealant effectiveness is strongly dependent on material retention and technique sensitivity. Self-adhering flowable composites offer simplified application with fewer clinical steps and may improve retention, especially in pediatric patients.
Eighty-eight children will be randomly allocated into four parallel groups (1:1:1:1): self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, and conventional resin-based sealant without fissurotomy.
Sealant retention will be assessed as the primary outcome using Simonsen's criteria, while secondary outcomes include caries development, marginal discoloration, and marginal integrity evaluated using Ryge criteria.
Clinical evaluations will be performed at baseline, 3, 6, and 12 months.
The findings of this study aim to provide evidence-based guidance on the optimal material and technique for pit and fissure sealing in children, potentially improving sealant longevity, reducing occlusal caries incidence, and enhancing preventive pediatric dental care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self adhering flowable composite Vertise™ Flow with fissurotomy | Experimental | Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition:
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| Self adhering flowable composite Vertise™ Flow without fissurotomy | Experimental | Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition:
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| Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. | Active Comparator | Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Matrix Composition:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy. | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Sealant retention | Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss | 3,6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Caries | Ryge criteria Alpha: Absence of caries Bravo: Prescence of caries | 3,6,12 months |
| Marginal discoloration | Ryge criteria Alpha: No discoloration anywhere on the margin around the sealant. Bravo: Visible partial discoloration on the margin around sealant. Charlie: Visible discoloration on the margin around all sealant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman MM Ramadan, Bachelors' | Contact | +201121592653 | eman.ramadan@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Adel ELbardissy, Professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | State/Province * | 11411 | Egypt |
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The blinding of the operator is not possible due to the nature of the materials used and fissurotomy preparation
| Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. |
| Active Comparator |
Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Composition:
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| Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. | Other |
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| Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. | Other |
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| Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. | Other |
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| 3,6,12 months |
| Marginal Integrity | Ryge criteria Alpha: Sealant had full adaptation to the adjacent tooth structure. Bravo: Evidence of gap detected by the tip of an explorer. | 3,6,12 months |
| Faculty of Dentistry, Cairo University | Cairo | State/Province * | Egypt |
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