Performance Of Class I Composite Restorations After Cavity Finishing By Air Abrasion Versus Diamond Stone

NCT06107218 | Unknown

• 1 other identifier: Air Abrasion in Finishing
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to reveal the performance of the resin composite restorations after finishing the cavity walls and margins using bioactive glass air abrasion particles in comparison to the routine finishing with the finishing diamond stone according to the FDI criteria for post operative sensitivity, marginal adaptation, marginal discoloration, secondary caries, and retention.

Conditions

Abrasion, Dental; Class I Dental Caries

Outcome Measures

Primary Outcomes (1)

• Post-operative sensitivity.

  The restorations will be assessed and evaluated by Visual Analogue Scale using Federation Dentaire Internationale (FDI) criteria. Visual Analogue Scale will be used by scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.

  24 hours Baseline, 6 and 12 months.

Secondary Outcomes (4)

• Marginal Discoloration.

  24 hours Baseline, 6, 12 and 18 months.

• Marginal Adaptation.

  24 hours Baseline, 6, 12 and 18 months.

• Occurrence of Caries.

  24 hours Baseline, 6, 12 and 18 months.

• Loss of Retention.

  24 hours Baseline, 6, 12 and 18 months.

Study Arms (2)

Diamond Stone group (Comparator)

ACTIVE COMPARATOR

Class I cavities will be finished using 20-30 μm grit extra fine (EF) yellow coded diamond stone with maximum rotational speed 300,000 min -1.

Other: Diamond Stone.

Bioactive Glass Air Abrasion group (Intervention)

ACTIVE COMPARATOR

Class I cavities will be finished by AquaCare Air Abrasion Device using bioactive glass air-abrasion particles (a mix of 30-60-90 μm particles). The nozzle of the air abrasion device will be 0.6 in diameter and angulated at 90° to the occlusal surface with a distance away from the tooth about 2-3 mm. The device will be used in a dynamic motion with 60 psi (4 Bar) adjusted pressure for 3 seconds.

Other: Bioactive Glass Air Abrasion Particles.

Interventions

Bioactive Glass Air Abrasion Particles. OTHER

Finishing of cavity walls by AquaCare Air Abrasion Device using Bioactive Glass Air Abrasion Particles.

Bioactive Glass Air Abrasion group (Intervention)

Diamond Stone. OTHER

Finishing of cavity walls using Diamond Stone.

Diamond Stone group (Comparator)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene (plaque index score 0 or 1).
• Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
• Patients approving to participate in the study.

You may not qualify if:

• Patients with known allergic or adverse reaction to the tested materials.
• Systematic disease that may affect participation.
• Xerostomic patients.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (22)

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MeSH Terms

Conditions

Tooth Abrasion

Condition Hierarchy (Ancestors)

Tooth Wear; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Mahmoud E Mahmoud, BDS

CONTACT

01226692855; mahmoud.essam@dentistry.cu.edu.eg

Asmaa A Yassen, Professor

CONTACT

01001912610; Asmaa.yaseen@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share