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

NCT05173753 | Unknown

• 1 other identifier: Surefil one in primary teeth
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• clinical effectiveness

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

  6 month intervene

Secondary Outcomes (3)

• The cost effectiveness

  6 month intervene

• Duration of procedure

  6 month intervene

• Child cooperation

  6 month intervene

Study Arms (2)

Novel self-adhesive composite restoration (Surefil one)

ACTIVE COMPARATOR

Other: Novel self-adhesive hybrid composite(Surefil one)

conventional composite resin restoration(VOCO Grandio)

ACTIVE COMPARATOR

Other: Novel self-adhesive hybrid composite(Surefil one)

Interventions

Novel self-adhesive hybrid composite(Surefil one) OTHER

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

Novel self-adhesive composite restoration (Surefil one); conventional composite resin restoration(VOCO Grandio)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children:
• Unable to attend follow-up visits. Refusal of participation.
• Teeth:
• Symptom tooth. Periapical Pathosis. Mobile primary tooth.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Kamal Aldin El Motayam, Professor

  Cairo University

  STUDY DIRECTOR

• Passant Nagi, PHD

  Cairo University

  STUDY DIRECTOR

• Mahitab M Abdel khalek, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

• Fatema H Mohamed, BDS

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

fatima E Rabie, BDS

CONTACT

1019685330; fatima.rabie@dentistry.cu.edu.eg

Passant Nagi, PHD

CONTACT

1280557107; passant.nagi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 30, 2021
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07