An interventional study of Control: Hand instrumentation for caries excavation and Intervention 1: EMS Airflow device for caries excavation in Dental Caries Extending Into Dentin and Root Caries, sponsored by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS. Active, not recruiting at 1 site in Switzerland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 62 is close to the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion criteria:
Post-hoc exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hand instrumentation for caries excavation
Procedure: Control: Hand instrumentation for caries excavation
Powder/water jet prophylaxis device (EMS Airflow) for caries excavation
Procedure: Intervention 1: EMS Airflow device for caries excavation
Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
Procedure: Intervention 2: Hand excavation + EMS Airflow device 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.
Also known as: Hand instrumentation 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.
Also known as: Powder/water jet prophylaxis device (EMS Airflow) 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.
Also known as: Hand excavation and Powder/ jet prophylaxis device (EMS Airflow) for caries excavation
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.
Time frame: 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.
Time frame: 1 year, year 1
Participants' Treatment preference
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.
Time frame: Through study completion, an average of 1 year
Started Sep 2021 (actual). Primary completion is estimated for Sep 2025, 48 months after the start.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 48 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Murali Srinivasan, Dr. med. dent., BDS, MDS, MBA, MAS