Clinical Performance of Bulk-fill Restorations in Class II Cavities

NCT06461364 | Completed DMC

• 1 other identifier: Walaa Hassan
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Direct composite resin restorations are considered an essential treatment option in the dental clinic because of increasing the demands for esthetics. These materials are primarily used as anterior and posterior filling materials for the restoration of dental caries, crown fractures, tooth wear, and congenital defects.

Conditions

Cavity, Dental

Outcome Measures

Primary Outcomes (3)

• FDI criteria Esthetic

  evaluated surface luster and surface staining

  from 3 months to 12 months

• FDI criteria Functional

  evaluated fracture of material and retention,occlusal contour and wear

  from 3 months to 12 months

• FDI criteria Biological

  Biological evaluated post operative hypersensitivity and recurrence caries

  from 3 months to 12 months

Study Arms (3)

Group A

EXPERIMENTAL

About 10 participants faced Self-adhesive composite (Surefil one)

Procedure: Assessment of cuspal deflection of bulk-fill restorations

Group B

EXPERIMENTAL

About 10 participants faced Viscalor

Procedure: Assessment of cuspal deflection of bulk-fill restorations

Group C

EXPERIMENTAL

About 10 participants faced Equiaforte

Procedure: Assessment of cuspal deflection of bulk-fill restorations

Interventions

Assessment of cuspal deflection of bulk-fill restorations PROCEDURE

To assess the performance of bulk-fill restorations on premolar teeth in class II cavities using some selected FDI criteria, a total sample size of 30 (10 for each group test) will be sufficient to detect: an effect size of 1.22 at a power (1-β error) of 0.8 and using a two-sided hypothesis test and a significance level (α error) 0.05 for data. Two teeth will be added to each group to compensate drop out samples.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients included in the study must be with at least two proximal caries teeth of ICDAS score 4.
• Patients with moderate and high caries risk index.
• Carious lesions will be standardized by means of clinical and radiographic examinations performed before the procedures.
• At least two permanent molars at one side requiring class ii caries lesions, with at least one neighboring tooth and in occlusion with antagonistic teeth.
• Moderate to large size cavities that extended into dentine, while maintain natural tooth contour.
• Absence of tooth mobility, tenderness, severe pain or pre-operative sensitivity.
• Normal occlusion relation with normal dentition

You may not qualify if:

• Teeth with deep dentinal lesions with pulpal involvement, abscess, pain or swelling
• Developmental disorders and adjacent soft tissue lesions.
• Patients with systemic illness will be excluded

Sponsors & Collaborators

• Egymedicalpedia: lead
• Al-Azhar University: collaborator

Study Sites (1)

Faculty of Dentistary - Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Wael Essam Jamil, Professor

  Al-Azhar Faculty of Dentistary for girls

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 17, 2024
• Study Start: July 20, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 25, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)