62
Participants
Start Date
September 30, 2021
Primary Completion Date
September 30, 2025
Study Completion Date
December 31, 2025
Control: Hand instrumentation for caries excavation
"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."
Intervention 1: EMS Airflow device for caries excavation
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.
Intervention 2: Hand excavation + EMS Airflow device for caries excavation
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.
Clinic of General, Special care, and Geriatric Dentistry, Center for Dental Medicine, University of Zurich, Zurich
Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
OTHER