Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.

Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial

The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: Novel self-adhesive hybrid composite(Surefil one)

Detailed Description

Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid & 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fatima E Rabie, BDS; Phone Number: +20 1019685330; Email: fatima.rabie@dentistry.cu.edu.eg
• Study Contact Backup: Name: Passant Nagi, PHD; Phone Number: +20 1280557107; Email: passant.nagi@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

Children:

Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation.

Teeth:

Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination.

Exclusion Criteria:

Children:

Unable to attend follow-up visits. Refusal of participation.

Teeth:

Symptom tooth. Periapical Pathosis. Mobile primary tooth.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Novel self-adhesive composite restoration (Surefil one)	Other: Novel self-adhesive hybrid composite(Surefil one); Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.
Active Comparator: conventional composite resin restoration(VOCO Grandio)	Other: Novel self-adhesive hybrid composite(Surefil one); Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical effectiveness	The two materials will be evaluated using the FDI World Federation criteria.	6 month intervene

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cost effectiveness	will be measured using the ICER (Incremental cost-effectiveness ratio)	6 month intervene
Duration of procedure	measure using stop watch	6 month intervene
Child cooperation	Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive).	6 month intervene

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Kamal Aldin El Motayam, Professor, Cairo University; Principal Investigator: Mahitab M Abdel khalek, BDS, Cairo University; Principal Investigator: Fatema H Mohamed, BDS, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Surefil one in primary teeth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes