Self-Adhesive Flowable Composite vs Conventional Sealant in Permanent Molars Retention
This study aims to compare the retention of self-adhesive flowable composite sealants versus conventional sealants in permanent molars using Simonsen's criteria, with the goal of preventing tooth decay.
Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.
+ Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.
+ Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.
Prevention Study
Summary
Study start date: March 1, 2026
Actual date on which the first participant was enrolled.This study focuses on comparing two types of dental sealants in children aged 6-8 years. The first is a self-adhering flowable composite, and the second is a conventional resin-based sealant. These sealants are applied to the newly erupted permanent first molars, with and without a procedure called fissurotomy. The main goal is to see which sealant works better and lasts longer in preventing dental caries, or cavities, in the deep grooves of these teeth. This research is important because it aims to find the best way to protect children's teeth, which could lead to fewer cavities and improved dental care. In this study, 88 children are divided into four groups. Each group receives one of the following: self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, or conventional resin-based sealant without fissurotomy. The main outcome measured is sealant retention, or how well the sealant stays in place. This is evaluated using a scoring system called Simonsen's criteria. Other outcomes include the development of cavities, marginal discoloration, and marginal integrity, which are assessed using Ryge criteria. These checks are done at the start of the study, and then after 3, 6, and 12 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.88 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 8 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorGroup IV
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Faculty of Dentistry, Cairo University
Cairo, EgyptOpen Faculty of Dentistry, Cairo University in Google MapsFaculty of Dentistry, Cairo University
Cairo, Egypt