Evaluation of Clinical Success of Bulk Fil Composite Versus Highly Viscous Glass Ionomer in Primary Class II Molars

Dental Caries Class II Clinical Trial

Official title:

"Evaluation of Clinical Performance of a Flowable Bulk Fill Composite Resin Versus a Highly Viscous Glass Ionomer Cement in Class II Cavities in Primary Molars: A Randomized Clinical Trial"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235489
• Other study ID #: PED 22-5D
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Mariam M Abdel Azim, Ass. Lec
• Phone: 0122841611
• Email: mariam.m.abdelazim[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

evaluate the clinical performance of EQUIA Forte ® ( a HVGIC) and Plafique® Bulk Flow composite resin when placed in class II cavities in primary molars.

Description:

1. Thorough diagnosis of patients will be done by the primary investigator. Patients with class II carious primary molars with score 4 or 5 using the International Caries Detections and Assessment Criteria (ICDAS).

2. Pre-operative bitewing radiographs will be obtained to assess the depth of the cavity. Primary molars with score D1 or D2 according to the ADA will be included in the study.

3. Each patient will be assigned to one of the two groups.

• Group I (n= 59): Plafique Bulk Flow Composite.

• Group II (n=59): EQUIA Forte Group.

4. Class II carious primary molars are prepared using 330 burs. The cavity will be approximately with a depth of 0.5 mm in dentin and width of at least one-third of the occlusal table. Outline of the cavity will be determined by the extent of the carious lesion. No beveling will be done in any of the cavities.

5. Matrix is placed and secured in position.

6. One of the 2 restorative materials is placed in the cavity using the manufacturer's instructions.

7. Patients will be recalled at 3, 6, and 12 months to evaluate the restoration clinically using the FDI criteria.

8. Patients will receive oral health education on how to maintain a proper oral hygiene and proper diet consumption.

9. They will be given manual tooth brushes and tooth pastes to use during the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• Four to 8 years old children

• Cooperative children classified as class 3 or 4 based on Frankle et al. classification.

• Presence of deep bite or any type of malocclusion or parafunctional habits.

• Children who have at least one primary molar with active proximal caries (score 4 or 5 using ICDAS).

Exclusion Criteria:

• Refusal of the parents to sign the informed consent.

• Presence of deep bite or any type of malocclusion or parafunctional habits.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

Intervention

Other:
• Palfique Bulk Flow
removal of caries in primary molars and placement of restorative materials

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical performance	Evaluate and compare the clinical performance of two commercially available bulk restorative materials (Plafique® Bulk Flow Composite and EQUIA Forte®) for 12 months using the Federation Dentaire Internationale (FDI) criteria when placed in class II cavity in primary molars.; This diagnostic system classified aesthetic, functional, and biological properties and covers various types of failures by using 16 different categories with five grades for each criterion.; Where score 1 indicates clinically excellent/very good (sufficient), 2: clinically good (sufficient), 3: Clinically satisfactory (sufficient), 4: Clinically unsatisfactory (partially insufficient), and finally score 5 indicates clinically poor (entirely insufficient)	one- year