Clinical Evaluation of Self-Adhesive Bulk-Fill Composite Versus Conventional Nano-hybrid Composite in Cervical Cavities

NCT06394440 | Recruiting DMC

• 1 other identifier: MIU-IRB-2223-177
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical trial is to compare the six months clinical performance of the self-adhesive bulk-fill composite with the conventional nano-hybrid composite in the cervical lesions of teeth in the esthetic zone. In addition, to evaluate patient's satisfaction towards the self-adhesive bulk-fill material and its total operatory time.

Conditions

Cervical Caries

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of the self-adhesive bulkfil composite in comparison to conventional composite

  Modified USPHS Criteria Alpha(A) Bravo(B) Charlie(C)

  Six months

Secondary Outcomes (1)

• Patient's Satisfaction of the final restorations

  Six Months.

Study Arms (2)

Self-Adhesive Bulkfill Composite Restoration

EXPERIMENTAL

Surefil One from Dentsply will be applied to one side of teeth that contain cervical cavities.

Combination Product: Self-Adhesive Bulkfill Composite (Surefil One)

Nano-hybrid Composite

ACTIVE COMPARATOR

Neospectra from Dentsply will be added after etching \& bonding to the other side of the teeth that contain cervical cavities.

Combination Product: Self-Adhesive Bulkfill Composite (Surefil One)

Interventions

Self-Adhesive Bulkfill Composite (Surefil One) COMBINATION_PRODUCT

It is a new self-adhesive bulkfill composite that requires no previous adhesive steps.

Nano-hybrid Composite; Self-Adhesive Bulkfill Composite Restoration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cervical lesions.
• Cervical lesions of at least one mm depth; to include enamel and dentin.
• Cervical lesions of not more than 3 mm in depth.
• Male or female genders.
• Medically free patients.
• Normal occlusion.
• Healthy Gingiva

You may not qualify if:

• Teeth showing signs of pulpitis or periapical pathosis.
• Patients older than 60 years.
• Patients younger than 18 years old.
• Pregnant women.
• Patients with history of allergy to resin.
• Patients with disabilities.
• Carious cervical lesions extending to proximal surfaces.
• Carious cervical lesions on the palatal/lingual surfaces.
• Teeth with root caries.
• Endodontically treated teeth.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, 11223344, Egypt

RECRUITING

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: May 1, 2024
• Study Start: March 14, 2023
• Primary Completion: July 20, 2024
• Study Completion: July 30, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 5 Years
• Access Criteria: Clinicaltrials.gov

Locations

EG (1)