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Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT

NCT07067164 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-07-16

No results posted yet for this study

Summary

Study Title:

Clinical Performance of Highly Viscous Glass Ionomer versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth: A 12-Month Randomized Clinical Study

Study Design:

Split-mouth, randomized clinical trial on 31 patients with at least two moderate Class II carious lesions in permanent posterior teeth. Each patient receives two restorations-bulk fill resin composite on one side and highly viscous glass ionomer (HVGIC) on the other.

Aim:

To compare the clinical performance of bulk fill resin composite and HVGIC restorations over 1 week (baseline), 6 months, and 12 months using the modified United States Public Health Services (USPHS) criteria.

Primary Outcome:

Marginal adaptation of the restorations

Secondary Outcomes:

1. Anatomic form
2. Contact point
3. Restoration retention
4. Marginal discoloration
5. Surface texture
6. Color match
7. Secondary caries
8. Postoperative sensitivity

Methodology Highlights:

Evaluation by two blinded examiners

Standardized cavity prep and material application

Clinical evaluation using USPHS criteria at all follow-up intervals

Statistical analysis with chi-square, ANOVA, or non-parametric tests as appropriate (R software v4.3.2)

Ethical Considerations:

Approved by the Faculty of Dentistry, Ain Shams University Research Ethics Committee

Informed consent will be obtained from all participants

Significance:

This study helps determine whether HVGIC can be a clinically viable alternative to bulk fill resin composite in moderate Class II cavities, with implications for durability, patient compliance, and cost-effectiveness

Conditions

  • Comparison of Bulk Fill vs HVGIC in Class II Cavities

Interventions

OTHER

Bulk fill resin composite restorative material

Both restorative materials were applied in a clinical setting following standard infection control protocols and material-specific preparation techniques. The interventions were performed by the same calibrated operator to ensure consistency, and evaluated using modified USPHS criteria by two blinded, independent assessors at 1 week (baseline), 6 months, and 12 months. The study employed a split-mouth design to allow direct intra-individual comparison between the two materials under similar oral conditions.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mohamed A Kamel, PhD · Associate Professor of Operative Dentistry Faculty of Dentistry Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07067164 on ClinicalTrials.gov