Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars

NCT06000085 | Unknown

• 1 other identifier: PED 22-4D
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in class II cavities of primary molars regarding the following objectives: The primary objective To evaluate and compare the clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after 3,6, and 12 months. The secondary objective To assess the effect of different independent variables on the treatment outcome of the experimental restorative materials. Research question: Is there a difference in the clinical performance between flowable giomers and highly viscous glass ionomer in restoring class II cavities of primary molars? Null Hypothesis There is no difference in the clinical performance between Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) after one year of follow up.

Conditions

Dental Caries Class II

Keywords

proximal caries; primary molars; flowable giomer; equia forte

Outcome Measures

Primary Outcomes (1)

• The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars

  The restorations will be evaluated using the FDI criteria having esthetic, functional, and biological properties

  12 months

Secondary Outcomes (1)

• The effect of different independent variables on the treatment outcome of the experimental restorative materials.

  12 months

Study Arms (2)

Flowable Giomer Beautifil flow plus x

EXPERIMENTAL

injectable flowable restorative material

Procedure: restoration of proximal cavities of primary molars with flowable giomer

Glass-hybrid-added HVGIC Equia Forte

ACTIVE COMPARATOR

Glass-hybrid-added Highly viscous glass ionomer cement

Procedure: restoration of proximal cavities of primary molars with highly viscous glass ionomer cement

Interventions

restoration of proximal cavities of primary molars with flowable giomer PROCEDURE

removal of proximal caries of primary molars and restoration of the cavities prepared by beautifil flow plus x

Flowable Giomer Beautifil flow plus x

restoration of proximal cavities of primary molars with highly viscous glass ionomer cement PROCEDURE

removal of proximal caries of primary molars and restoration of the cavities prepared by equia forte

Glass-hybrid-added HVGIC Equia Forte

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 8 years old medically free children.
• Cooperative children classified as class 3 or 4 based on Frankel et al. classification
• Children who had at least one active dentinal carious lesion on proximal surface of primary molars
• Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
• Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
• Simple or compound class II cavities be present
• The antagonist and the adjacent tooth should be present
• Primary molar should have at least 2/3 of the root present

You may not qualify if:

• Refusal of the parents to sign the informed consent
• Presence of deep bite or any pictures of malocclusion and any parafunctional habits.
• Presence of any unprovoked pain, pulp exposure,clinical swelling, abscess or fistula.
• Presence of any physiological or pathological mobility.
• Very deep subgingival cavities
• Teeth with congenitally missing successor

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry ain shams university

Cairo, Egypt

RECRUITING

Study Officials

• Sarah Emad

  faculty of dentistry ain shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Emad

CONTACT

01005699595; dent.sarah.emad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at the Pediatric Dentistry and Dental Public Health Department-Faculty of Dentistry

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: December 30, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)