Dental caries (decay) Oral Health
Conditions
Interventions
The interventions being evaluated, Selective Caries Removal (SCR) and the best alternative Complete Caries Removal (CCR) differ solely in the amount of carious dentine removed during the excavation ph
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 12 years and over 2. Suitable to receive either clinical procedure 3. Receive some or all of their treatment under the NHS 4. One (or more) pre-molar or molar teeth with caries (primary or secondary) extending into the pulpal third of dentine 5. Caries may be proximal and/or occlusal and the lesion will be suitable for filling with a single restoration
Exclusion criteria
Exclusion criteria: Carious tooth shows signs or symptoms of irreversible pulp pathology or loss of vitality including the presence of a sinus, tenderness to percussion, buccal tenderness, pathological mobility, severe sensitivity or evidence of pathology on a periapical radiograph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained tooth vitality will be assessed at routine dental visits, recorded in the CRF and used in a time-to-event framework defined as the time from randomisation to root canal treatment or extraction due to loss of vitality. The primary time point of interest is 3 years. Sustained tooth vitality will be determined by the absence of root canal treatment or extraction due to loss of vitality and the absence of clinical signs and symptoms of pulp death including evidence from radiographs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: 1. Pulp exposure during caries removal measured following intervention with a yes/no answer in the case report forms asking "Was dental pulp tissue exposed/bleeding from the pulp observed?" 2. Progression of caries measured on examination at dental follow-up visits on a CRF question with a yes/no answer that asks "Was progression of caries identified through radiograph or clinical assessment?" 3. Tooth restoration failure and re-restoration measured on examination at dental follow-up visits or from routinely collected data before the end of the study by recording the treatment provided. Patient-centred: 4. Dental pain measured using the 11-point Numerical Pain Rating Scale (NPRS-11) on participant questionnaires at baseline, 1, 2 and 3 years post-randomisation 5. Need for dental pain relief measured by asking “Did you take any dental pain relief medication?” on participant questionnaires at baseline, 1, 2 and 3 years post-randomisation 6. Health status measured using the EQ-5D-5L on participant questionnaires at baseline, 1, 2 and 3 years post-randomisation 7. Oral Health-Related Quality of Life measured using the short form Oral Health Impact Profile (OHIP-14) on participant questionnaires at baseline, 1, 2 and 3 years post-randomisation 8. Oral health behaviours measured using 4 non-standardised but previously used questions on participants questionnaires at baseline and 3 years post-randomisation 9. Patient satisfaction measured on participants questionnaires at 1-year post-randomisation using 3 satisfaction questions from NHS England commissioning of dental services guidelines and 1 general satisfaction question tailored to the trial intervention repeated at 1, 2 and 3 years post-randomisation Economic outcomes measured over 3 years and modelled over a life time horizon: 10. NHS perspective on costs defined as intervention delivery costs (sourced from a dental practice completed CRF at baseline) and remaining follow up care, which will be sourced fr | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactRuth;Jan Floate;Clarkson
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Outcome results
None listed