Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations

Not Applicable

Active, not recruiting

• Conditions: Dental Caries Extending Into Dentin; Root Caries

• Registration Number: NCT04822246
• Lead Sponsor: Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-30
• Study Start: 2021-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Restoration Success rate	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	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 Outcome Measures

Name	Time	Method
Participants' Treatment preference	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.

Trial Locations

Locations (1)

Clinic of General, Special care, and Geriatric Dentistry, Center for Dental Medicine, University of Zurich; 🇨🇭 Zurich, Switzerland