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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Restoration Success rate
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Control: Hand instrumentation for caries excavation
Hand instrumentation for caries excavation
Intervention: Control: Hand instrumentation for caries excavation (Procedure)
Intervention 1: EMS Airflow device for caries excavation
Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
Intervention: Intervention 1: EMS Airflow device for caries excavation (Procedure)
Intervention 2: Hand excavation + EMS Airflow device for caries excavation
Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
Intervention: Intervention 2: Hand excavation + EMS Airflow device for caries excavation (Procedure)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Participants' Treatment preference(Through study completion, an average of 1 year)
Investigators
Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
Prof.
University of Zurich