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

Ain Shams University

Status: Enrolling

Conditions: Dental Caries Class II

Treatments: Other: Palfique Bulk Flow

Study type: Interventional

Funder types: Other

Identifiers

NCT06235489

PED 22-5D

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 2 patient groups

Palfique Bulk Flow bulk-fil flowable restorative material

Experimental group

Description:

Procedure: restoration of proximal cavities of primary molars with bulk-fil flowable composite removal of proximal caries of primary molars and restoration of the cavities prepared by Palfique bulk flow

Treatment:

Other: Palfique Bulk Flow

Glass-hybrid added HVGIC Equia Forte HT Glass-hyrbid-added highly viscous glass ionomer cement

Active Comparator group

Description:

Procedure: Restoration of proximal cavities of primary molars with highly viscous glass ionomer cement removal of proximal caries of primary molars and restoration of the cavities prepared by the Equia forte HT

Treatment:

Other: Palfique Bulk Flow