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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05173753

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Other: Novel self-adhesive hybrid composite(Surefil one)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

clinical effectiveness [6 month intervene]
The two materials will be evaluated using the FDI World Federation criteria.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Kamal Aldin El Motayam, Professor, Cairo University
Study Director: Passant Nagi, PHD, Cairo University
Principal Investigator: Mahitab M Abdel khalek, BDS, Cairo University
Principal Investigator: Fatema H Mohamed, BDS, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatima Elfadil Rabie, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05173753

Other Study ID Numbers:

Surefil one in primary teeth

First Posted:

Dec 30, 2021

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jul 27, 2022