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

Primary Purpose

Dental Caries in Children

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Novel self-adhesive hybrid composite(Surefil one)

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Novel self-adhesive composite restoration (Surefil one)

conventional composite resin restoration(VOCO Grandio)

Arm Description

Outcomes

Primary Outcome Measures

clinical effectiveness

The two materials will be evaluated using the FDI World Federation criteria.

Secondary Outcome Measures

The cost effectiveness

will be measured using the ICER (Incremental cost-effectiveness ratio)

Duration of procedure

measure using stop watch

Child cooperation

Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive).

Full Information

NCT ID

NCT05173753

First Posted

December 4, 2021

Last Updated

July 25, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05173753

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2022 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Novel self-adhesive composite restoration (Surefil one)

Arm Type

Active Comparator

Arm Title

conventional composite resin restoration(VOCO Grandio)

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Novel self-adhesive hybrid composite(Surefil one)

Intervention Description

Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.

Primary Outcome Measure Information:

Title

clinical effectiveness

Description

The two materials will be evaluated using the FDI World Federation criteria.

Time Frame

6 month intervene

Secondary Outcome Measure Information:

Title

The cost effectiveness

Description

will be measured using the ICER (Incremental cost-effectiveness ratio)

Time Frame

6 month intervene

Title

Duration of procedure

Description

measure using stop watch

Time Frame

6 month intervene

Title

Child cooperation

Description

Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive).

Time Frame

6 month intervene

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

fatima E Rabie, BDS

Phone

1019685330

Ext

+20

fatima.rabie@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Passant Nagi, PHD

Phone

1280557107

Ext

+20

passant.nagi@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamal Aldin El Motayam, Professor

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Passant Nagi, PHD

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mahitab M Abdel khalek, BDS

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fatema H Mohamed, BDS

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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