Performance Of Cervical Restorations Using Nitric Acid and Mineral Enriched Adhesive Versus Phosphoric Acid and Universal Adhesive

NCT05928533 | Completed DMC

• 1 other identifier: Nourane Yasser Ali Mohamed
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical performance of multifunction Nitric acid etch, mineral enriched adhesive and flowable resin composite liner versus the universal adhesive in etch and rinse mode and regular flowable liner in cervical carious anterior cavities.

Conditions

Clinical Performance

Keywords

clinical performance, cervical caries, bioactive restoration, nitric acid, universal adhesive

Outcome Measures

Primary Outcomes (1)

• Post operative sensitivity

  Modified USPHS criteria United states public health service

  24hours, 6, 12 and18 months

Secondary Outcomes (4)

• Marginal deterioration

  24 hours,6,12 and 18 months

• Marginal discoloration

  24 hours, 6, 12 and 18 months

• Retention

  24 hours,6,12 and 18 months

• Secondary caries

  24 hours,6,12 and 18 months

Study Arms (2)

Scotchbond Etchant gel ,Single Bond Universal adhesive , Filtek Supreme flowable composite of 3M

ACTIVE COMPARATOR

After cavity preparation, enamel and dentin will be etched for 15 seconds using Scotchbond Universal Etchant gel 3M. The surface will be rinsed for 10 seconds and dried with compressed air, removing all excess moisture without desiccating the dentin structure then apply two coats of Single Bond Universal adhesive 3M with a micro brush with rubbing action for 20 seconds then evaporate the solvent with gentle air stream until no movement is noticed in the adhesive then finally light cured for 10 seconds. A Filtek Supreme 3M flowable composite will be used to restore the prepared cavity after selecting the appropriate shade. The shade selection for the flowable composite will be done before the cavity preparation. The flowable composite will be applied in increments of 2mm thickness then light cured for 40 seconds using LED light curing unit.

clean and boost enamel cleanser, RE GEN universal adhesive & flowable composite of vista apex.

EXPERIMENTAL

After cavity preparation, clean and boost enamel cleanser of vista apex will be used to clean enamel and dentin surface by three steps: 1. With the enclosed flow-thru brush tip, apply Clean \& Boost to the surface to be cleansed, ensuring the surface is completely saturated. 2. Using the delivery brush tip, agitate the Clean \& Boost on the surface for 10 seconds. 3. Rinse thoroughly. The RE GEN universal adhesive from vista apex will be applied with micro brush with rubbing action then air agitation. RE GEN Bio active flowable composite form vista apex will be added to the universal adhesive and then cured together for 20 seconds according to the manufacture instructions.

Interventions

clean and boost enamel cleanser of vista apex , RE GEN universal adhesive from vista apex , RE GEN Bio active flowable composite form vista apex OTHER

the clean and boost use to clean the tooth surface after cavity preparation without causing severe form of hypersensitivity then the RE GEN universal adhesive is applied by using a brush and cured with the RE GEN flowable composite for 20 seconds. Curing both together increase the bioactivity of the material.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cervical carious anterior lesions.
• Age: (18-45Ys)
• Gender: male and female
• Low and moderate caries risk patient

You may not qualify if:

• Patients with poor oral hygiene.
• Presence of para functional habits.
• Systemic diseases or severe medical complications.
• Lack of compliance.
• Rampant caries.
• Xerostomia

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Olfat El sayed Hassanein, Professor

  Olfat.hassanein@dentistry.cu.edu.eg

  STUDY DIRECTOR

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: Principle investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 3, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2023- January 2025
• Access Criteria: Norane yasser (Principle investigator), through a folder saved on the computer with password

Locations

EG (1)