Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations (ART-AIRFLOW)

December 3, 2024 updated by: Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS

Excavation of Root Caries with Air-water Powder Stream Vs Manual Excavation for Atraumatic Restorative Treatment in Older Patients: a Single-blind Randomized Controlled Trial

The main objective of this RCT is to compare the efficacy of a powder/water jet prophylaxis device and conventional hand excavation in excavating root surface caries, with regard to restoration survival/success in older adults.

The secondary outcome of this RCT is to assess the participants' treatment preferences for the received treatment with regard to the procedures involved and in the invasiveness of the procedures carried out during the ART restoration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

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 Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Clinic of General, Special care, and Geriatric Dentistry, Center for Dental Medicine, University of Zurich

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Adults ≥65 years
  • Dentinal root caries lesions with no painful symptomology
  • Can follow instructions for oral hygiene
  • Not dependent for care for their ADLs.

Exclusion criteria:

  • Symptomatic carious teeth
  • Non-carious attrition, erosion or abrasion cavities
  • Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
  • Not willing or able to sign informed consent

Post-hoc exclusion:

  • Participant withdraws consent
  • Medical reasons.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control: Hand instrumentation for caries excavation
Hand instrumentation for caries excavation
Procedure: Control: Hand instrumentation for caries excavation
An enamel hatchet will be used to create access to the carious lesion and then removal of soft carious tissue will be undertaken with excavators. Excavation will be stopped when some resistance to excavation will be felt and the cavity will be then conditioned with polyacrylic acid for 20 s, washed and dried with cotton pellets. A high-viscosity glass-ionomer cement will be used to restore the cavity. Moisture control will be achieved with the use of cotton wool rolls. A chair-side assistant will hand-mix the glass-ionomer according to manufacturers' instructions and it will be placed in the cavity using the "press-finger" technique whenever the type of cavity allows it. In the case of root restorations, a glove coated with petroleum jelly will be used similarly to the "press-finger" technique to better condense the material into the cavity. Excess material will be removed; the restoration will be coated with petroleum jelly. No local anaesthetic will be used to provide ART treatment.
Other Names:
  • Hand instrumentation for caries excavation
Experimental: Intervention 1: EMS Airflow device for caries excavation
Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
Procedure: Intervention 1: EMS Airflow device for caries excavation
An enamel hatchet will first be used to gain access into the cavity. Then the powder-water prophylaxis device will be used for the removal of soft carious tissue with the sodium bicarbonate powder-water jet. Excavation will be stopped when the colour of the lesion begins to darken and all the soft deposits are evacuated. The excavation will be done intermittently allowing sufficient time to check with hand instrument the surface hardness of the lesion. If the lesion is still soft excavation will be continued until the surface is hard suitable for restoring. The cavity will be then rinsed with copious water spray to evacuate all the powder-water material. The restoration procedure with a glass-ionomer cement will be done following the same procedures as in the control group.
Other Names:
  • Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
Experimental: Intervention 2: Hand excavation + EMS Airflow device for caries excavation
Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
Procedure: Intervention 2: Hand excavation + EMS Airflow device for caries excavation
The participants allocated to this group will have the caries excavated as described for the control group. Then prior to filling the excavated cavity, the procedure of sodium bicarbonate powder-water jet irrigation as described for the intervention group #1 will be performed to condition the prepared excavated cavity. Then the restorative procedure will be completed with the restorative material and procedures as described for the previous groups.
Other Names:
  • Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration Success rate
Time Frame: 1 year, year 1
Restoration success rate (SxR %): For the purpose of this trial, a successful restoration is defined as one that has undergone no changes in its surface / structural integrity, still adhered to the structure and is functional when examined during the scheduled or unscheduled recall visit. The restoration success rate (SxR %) is calculated by the number of successful restorations present at the end of the trial (nsx) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SxR % = (nsx / N0) * 100.
1 year, year 1
Restoration survival rate
Time Frame: 1 year, year 1
Restoration survival rate (SvR %): For the purpose of this trial, any restoration, where the surface or structural integrity is compromised, but still adhering to the tooth, is functional and does not warrant a repair or replacement when examined during the scheduled or unscheduled recall visit, is considered survived. The restoration survival rate (SvR %) is calculated by the number of survived restorations present at the end of the trial (nsv) divided by the number of restorations placed in the beginning of the trial (N0) multiplied by 100 using the formula: SvR = (nsv / N0) * 100.
1 year, year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' Treatment preference
Time Frame: Through study completion, an average of 1 year

Secondary assessment will be to assess the participants' treatment preference. This is done by administering a simple questionnaire which inquires on their treatment preferences.

After treatment will be completed the dental nurse will question the participant about their treatment preference. The questions will include preferences for restorative treatment with or without the use of anaesthesia, with or without rotary instrumentation, hand instrumentation or with air-water prophylaxis device, compared to their previous dental experience. The response "no difference" will also an option.
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS

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 (Actual)

September 30, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZH_ABS_2021_4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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