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

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

Status: Active, not recruiting

Conditions: Dental Caries Extending Into Dentin; Root Caries

Treatments: Procedure: Control: Hand instrumentation for caries excavation; Procedure: Intervention 1: EMS Airflow device for caries excavation; Procedure: Intervention 2: Hand excavation + EMS Airflow device for caries excavation

Study type: Interventional

Funder types: Other

Identifiers

NCT04822246

UZH_ABS_2021_4

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 3 patient groups

Control: Hand instrumentation for caries excavation

Other group

Description:

Hand instrumentation for caries excavation

Treatment:

Procedure: Control: Hand instrumentation for caries excavation

Intervention 1: EMS Airflow device for caries excavation

Experimental group

Description:

Powder/water jet prophylaxis device (EMS Airflow) for caries excavation

Treatment:

Procedure: Intervention 1: EMS Airflow device for caries excavation

Intervention 2: Hand excavation + EMS Airflow device for caries excavation

Experimental group

Description:

Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation

Treatment:

Procedure: Intervention 2: Hand excavation + EMS Airflow device for caries excavation