Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations
NCT ID: NCT04822246
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
62 participants
INTERVENTIONAL
2021-09-30
2025-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control: Hand instrumentation for caries excavation
Hand instrumentation for caries excavation
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
Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
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
Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dentinal root caries lesions with no painful symptomology
* Can follow instructions for oral hygiene
* Not dependent for care for their ADLs.
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
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Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
OTHER
Responsible Party
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Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS
Prof.
Locations
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Clinic of General, Special care, and Geriatric Dentistry, Center for Dental Medicine, University of Zurich
Zurich, , Switzerland
Countries
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Other Identifiers
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UZH_ABS_2021_4
Identifier Type: -
Identifier Source: org_study_id