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

NCT04822246 | Active Not Recruiting

• 1 other identifier: UZH_ABS_2021_4
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries Extending Into Dentin; Root Caries

Keywords

Root caries; Elders; Atraumatic restorative treatment; Glass-ionomer cement

Outcome Measures

Primary Outcomes (2)

• Restoration Success rate

  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

  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 Outcomes (1)

• Participants' Treatment preference

  Through study completion, an average of 1 year

Study Arms (3)

Control: Hand instrumentation for caries excavation

OTHER

Hand instrumentation for caries excavation

Procedure: Control: Hand instrumentation for caries excavation

Intervention 1: EMS Airflow device for caries excavation

EXPERIMENTAL

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

Procedure: Intervention 1: EMS Airflow device for caries excavation

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

EXPERIMENTAL

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

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

Interventions

Control: Hand instrumentation for caries excavation PROCEDURE

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.

Also known as: Hand instrumentation for caries excavation

Control: Hand instrumentation for caries excavation

Intervention 1: EMS Airflow device for caries excavation PROCEDURE

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.

Also known as: Powder/water jet prophylaxis device (EMS Airflow) for caries excavation

Intervention 1: EMS Airflow device for caries excavation

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

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.

Also known as: Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Participant withdraws consent
• Medical reasons.

Sponsors & Collaborators

• Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS: lead

Study Sites (1)

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

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Root Caries

Interventions

Powders

Condition Hierarchy (Ancestors)

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: Single-blind, RCT

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 30, 2021
• Study Start: September 30, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-11

Locations

CH (1)