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Active, Not Recruiting

NCT Number: NCT04822246

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Caries Extending Into Dentin Dental Caries Root Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: Powder/water jet prophylaxis device (EMS Airflow) 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.

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

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: ART-AIRFLOW

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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