Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT

Clinical Performance of a Self-Cure Composite System Versus a Highly Filled Flowable Composite System in Carious Cervical Lesions: A Randomized 18 Months Clinical Trial

The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.

Study Overview

• Status: Not yet recruiting
• Conditions: Carious Cervical Lesions
• Intervention / Treatment: Procedure: Class V Restoration

Detailed Description

Examination and selection of patients will be done according to the inclusion and exclusion criteria. A class V cavity will be prepared after local anesthesia has been given. Followed by the placement of the restorative material according to the randomization sequence.

For the intervention: the primer will be applied first followed by filling of the cavity using self cure composite (Stella Automix or Stela Capsule, SDI Ltd, Australia). For the control group: etching of the cavity (Kulzer Gluma Etch, Kulzer GmbH, Germany) will be done followed by rinsing, drying, applying the bonding agent (Solobond M, Voco GmbH, Germany), curing, and lastly, applying the highly filled flowable composite (Polofil NHT flow, Voco Gmbh, Germany) and curing.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman Hamza, Bachelor of Science; Phone Number: +20 1063330630; Email: abdelrahmanh.hamza@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University
    • Contact: Abdelrahman Hamza, Bachelor of Science; Phone Number: +20 1063330630; Email: abdelrahmanh.hamza@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Patient-related Criteria:

A) Inclusion Criteria:

• Patients consulting in the outpatient clinic with cervical carious lesion.
• Age between 21-45 years.
• Males and females.

B) Exclusion Criteria:

• Systemic disease or severe medical complication.
• Allergy to any of the restorative materials.
• Pregnancy.
• Disabilities.
• Heavy smoking; xerostomia.
• Lack of compliance.
• Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.

Tooth-related Criteria:

A) Inclusion Criteria:

• Small to moderate class V carious lesion.
• Teeth are vital with no signs of irreversible pulpitis.
• Caries cervical margins above the CEJ.
• Well-formed and fully erupted in normal functional occlusion with natural antagonist.

B) Exclusion Criteria:

• Deciduous teeth; as the study is targeting only permanent teeth.
• Deep carious defects (close to the pulp, less than 1 mm distance).
• Tooth hypersensitivity.
• Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
• Heavy occlusion and occlusal contacts or history of bruxism.
• Endodontically treated teeth.
• Periapical pathology or signs of pulpal pathology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-cure Bulk Fill Resin Composite (Stela Automix or Stela Capsule, SDI Limited, Australia); Stela primer will be applied first after cavity preparation then Stela self-cure composite without curing.	Procedure: Class V Restoration; A class V cavity will be prepared after administering local anesthesia. Rubber dam isolation will be done followed by placement of the restorative material according to the randomization sequence.
Active Comparator: Highly Filled Flowable Composite (Polofil NHT flow, Voco GmbH, Germany); After total etching of the cavity and bonding, the highly filled flowable composite will be applied in increments then cured.	Procedure: Class V Restoration; A class V cavity will be prepared after administering local anesthesia. Rubber dam isolation will be done followed by placement of the restorative material according to the randomization sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	The restoration will be clinically assessed according to the modified USPHS criteria. Restoration will be given Alpha score when there is no loss of restoration. It will be given a Charlie score when there is loss of restoration and need for replacement.	18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Adaptation	The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when the restoration is closely adapted with no detectable margin. It will be given a Bravo score when there is a detectable marginal discrepancy, but it still clinically acceptable. It will be given a Charlie score when there is a marginal crevice that is clinically unacceptable.	18 months
Marginal Discoloration	The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no discoloration between the tooth and the restoration. It will be given a Bravo score when there is superficial discoloration which can be polished away. It will be give a Charlie score when the discoloration has penetrated beyond the margin in pulpal direction.	18 months
Post-operative Sensitivity	The restoration will be clinically assessed according to the modified USPHS criteria. It will be give an Alpha score when there is no post-operative sensitivity and a Charlie score when there is post-operative sensitivity.	18 months
Recurrent Caries	The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no detectable recurrent caries and a Charlie score when recurrent caries is detected.	18 months
Surface Roughness	The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when there is no surface defect. It will be given a bravo score when there is minimal surface defect. It will be given a charlie score when there is a severe surface defect.	18 months
Color Match	The restoration will be clinically assessed according to the modified USPHS criteria. It will be given an Alpha score when the restoration matches the color of the tooth. It will be give a Bravo score when there is an acceptable mismatch. It will be given a Charlie score when there is an unacceptable mismatch.	18 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Class V; Cervical Carious Lesions; Self-cure Composite; Highly Filled Flowable Composite; Stela
• Other Study ID Numbers: Self-cure Bulk fill Resin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No