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

November 14, 2023 updated by: Mahmoud Essam Mahmoud, Cairo University

Performance Of Occlusal Resin Composite Restorations Following Cavity Finishing Using Bioactive Glass Air Abrasion Versus Diamond Stone: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraoral air abrasion is the process of altering the surface of the tooth structure through the use of abrasive particles propelled by compressed air or other gasses. The use of intraoral air abrasion has become practical with devices that simultaneously output abrasive particles and water to control the spread of the particles. There are different types of abrasive particles maybe used depending on the clinical application for which the intraoral air abrasion is being performed. Intraoral air abrasion may also be used as a tool for dental prophylaxis, often called air polishing.

Different particles could be incorporated into air abrasion devices according to the intended use of them, such as aluminum oxide (alumina), Calcium Sodium Phosphosilicate (Biactive Glass) and Sodium bicarbonate. To obtain maximum cutting efficiency, the particle should be hard enough to indent the substrate it abrades, and irregular in shape with a sharp cutting edge. Round and smooth particles possess poor abrasive properties, so it may be used for polishing needs "air- polishing". Increased air pressure provided an increased number and velocity of the particles. Abrading power must be proportional to kinetic energy of the particles, which is the function of mass and velocity of the particle. The cutting efficiency of air abrasion depends on several criteria, such as: size, shape, hardness, density of the particles and air pressure.

Aluminum oxide (alumina) are the most abrasive type of particles used. They are irregular in shape with different particle sizes. Intraoral sandblasting with alumina particles (Al2O3) was first described in 1945 by Black. Initially, it was reported that the bond strength to the tooth surface improved, also confirmed by recent investigations, and some authors adopted its use in clinical procedures even after preparing the cavity with rotating instrument. A bioactive glass abrasive, is also commercially available but indicated for the purpose of tooth polishing. Some work has also showed potential for it to have selective cutting properties. However, its cutting time can take 2-3 times longer than alumina, making it clinically indicated for cavity finishing and not cutting.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diamond Stone group (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.
Finishing of cavity walls using Diamond Stone.
Active Comparator: Bioactive Glass Air Abrasion group (Intervention)
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.
Finishing of cavity walls by AquaCare Air Abrasion Device using Bioactive Glass Air Abrasion Particles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative sensitivity.
Time Frame: 24 hours Baseline, 6 and 12 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Discoloration.
Time Frame: 24 hours Baseline, 6, 12 and 18 months.
The restorations will be assessed by visual examination and short air drying. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
24 hours Baseline, 6, 12 and 18 months.
Marginal Adaptation.
Time Frame: 24 hours Baseline, 6, 12 and 18 months.
The Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
24 hours Baseline, 6, 12 and 18 months.
Occurrence of Caries.
Time Frame: 24 hours Baseline, 6, 12 and 18 months.
The Method of restorations assessment will be Tactile using different sized explorers. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
24 hours Baseline, 6, 12 and 18 months.
Loss of Retention.
Time Frame: 24 hours Baseline, 6, 12 and 18 months.
The restorations will be assessed by visual examination and short air drying. Assessment will be done using FDI criteria and recorded as scores from 1 to 5, where scores from 1 to 5 will indicate clinically excellent/very good, clinically good, clinically satisfactory, clinically unsatisfactory and clinically poor respectively.
24 hours Baseline, 6, 12 and 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Air Abrasion in Finishing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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