An interventional study of Visual-tactile caries examination and Visual-tactile caries examination and bilateral bitewing radiography in Dental Caries, Teeth Loss and Necrosis of Pulp, sponsored by Jukka Leinonen. Not yet recruiting at 1 site in Finland. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Jukka Leinonen · Not applicable, Interventional, and Diagnostic
Dentists commonly use bitewing radiographs (dental X-rays) together with a visual-tactile (clinical) examination to detect cavities between the back teeth. While bitewing radiography can identify some lesions that are not visible during a visual-tactile examination, it is unclear whether its use improves outcomes that are important to patients. Radiographs may lead to the detection and treatment of lesions that would not otherwise cause problems, resulting in additional costs and dental procedures. Despite the widespread use of bitewing radiography in adult dental care, its effects on treatment decisions, patient outcomes, and cost-effectiveness have not been evaluated in randomized controlled trials among adults.
Therefore, the investigators aim to conduct a randomized controlled trial to compare two strategies for caries diagnosis in young adults: visual-tactile examination alone and visual-tactile examination supplemented with bitewing radiography. Participants will undergo a standardized oral examination and will be randomly assigned to one of the two diagnostic strategies. Treatment recommendations will be based on the findings obtained using the allocated diagnostic approach and will follow predefined treatment criteria.
The investigators will compare the effects of these diagnostic strategies on patient-important outcomes, treatment decisions, resource use, examination time, and cost-effectiveness. The results of this study will provide evidence on whether including bitewing radiography in routine caries diagnostics offers benefits that justify its additional costs and radiation exposure in young adults.
Background: Visual-tactile examination is the primary method to detect and classify caries lesions, but bitewing radiography may complement it when examining approximal surfaces of posterior teeth. Bitewing radiography is used in 30% of periodic oral examinations in Finnish communal dental clinics, but the frequency varies greatly among dentists. The effect of bitewing radiography on caries treatment, patient-important outcomes, and cost-effectiveness has not been assessed in randomized controlled trials among adults. The only comparable trial, performed among 3-6-year-old children, found that bitewing radiography brought more harm than benefits. As the dentition and caries expression of adults differ substantially from those of young children, dedicated evidence for adults is needed.
Aim: To conduct a randomized controlled trial assessing patient-important outcomes resulting from including bitewing radiography in caries diagnostics in Finnish young adults.
Methods: This single-center, two-arm RCT follows SPIRIT and CONSORT guidelines and is a substudy of the ongoing PANIC study. Close to 500 PANIC participants will be invited to the 20-year follow-up oral examination starting in spring 2027, when they are about 27 years old. All assenting participants will undergo a strictly predefined visual-tactile examination by two calibrated dentists, covering masticatory system, mucosa, periodontium, dentition, and occlusion.
Allocation: About 250 participants are expected to attend, most of them eligible. Eligible participants will be randomized 1:1 using stratified block randomization (block sizes 4-6) at sealedenvelope.com to either receive a further bitewing radiographic examination or not. The random sequence will be generated by a researcher not involved in the examinations.
The bitewing radiography includes bitewing radiographs from both sides of the jaw, their review in a dark room with dedicated software and an optimized screen, and a second clinical examination for surfaces where the first visual-tactile examination and radiographic examination disagree. Radiographs will be examined by both the examining dentist and a dentist specializing in dental radiology. They will be calibrated before the start of the examinations.
Treatment plan: All participants will receive a structured treatment plan following pre-specified indications for treatment. All participants will be recommended daily tooth brushing. Indications for caries treatment are a) caries lesions that are not cleanable due to undermining cavitation, b) symptomatic caries lesions, c) caries lesions that have caused so much tooth substance loss that the tooth no longer is in occlusion, d) caries lesions causing a significant aesthetic impairment and e) caries lesions that threaten tooth vitality. The treatment plans for masticatory system, mucosa, periodontium and occlusion follow Finnish Current Care Guidelines. The treating dentist will be able to review the bitewing radiographs that have been taken in the baseline examination or take bitewing radiographs herself/himself. The treatment provided will be followed using patient records.
Follow-up: All participants will be followed electronically using national and local patient registers. Treatments will be categorized using standardized national codes maintained by the National Institute for Health and Welfare.
Sample size: No prior data are available for a formal sample size calculation; a convenience sample of the \~250 expected attendees will be used.
Statistical analyses: Effects on outcomes will be analyzed using suitable linear or generalized linear models, adjusting for relevant baseline data. Examination step times and planned treatments will be compared across arms. Cost-effectiveness will be evaluated by comparing costs and outcomes across arms. Analysts will be blinded to allocation. A detailed statistical analysis plan will be finalized after trial completion and before unblinding.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's planned enrollment of 250 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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I) More than 1 year since previous bitewing radiography II) At least two neighboring posterior teeth with approximal contact
III) Based on clinical assessment, at least one of the following:
more than one of the predefined risk factors for caries
Exclusion Criteria:
Standardized visual-tactile caries examination only.
Diagnostic Test: Visual-tactile caries examination
Standardized visual-tactile caries examination supplemented with bilateral bitewing radiography.
Diagnostic Test: Visual-tactile caries examination and bilateral bitewing radiography
Participants undergo a standardized visual-tactile dental examination for caries detection without bitewing radiography. Treatment recommendations are based on visual-tactile findings and predefined treatment criteria.
Also known as: clinical examination, oral examination, clinical oral examination, visual caries examination
Participants undergo a standardized visual-tactile dental examination supplemented with bilateral bitewing radiography. Treatment recommendations are based on combined visual-tactile and radiographic findings and predefined treatment criteria.
Also known as: bitewing examination, bitewing radiographics, radiological caries examination, bitewing X-ray examination, bitewing radiographic examination
Number of caries lesions indicated for operative treatment
Number of caries lesions that are indicated for restorative treatment, endodontic treatment or extraction. Indications for restorative treatment are a) caries lesions that are not cleanable due to undermining cavitation, b) symptomatic caries lesions, c) caries lesions that have caused so much tooth substance loss that the tooth no longer is in occlusion, d) caries lesions causing a significant aesthetic impairment and e) caries lesions that threaten tooth vitality. Extraction is indicated for caries lesions that cannot be restored well. Endodontic treatment is indicated for caries lesions that have caused irreversible pulpitis or necrosis of the pulp.
Time frame: At the baseline examination
Number of teeth that have received operative treatment
The number of teeth that have received operative treatment will be composed by number of 1. teeth that have received a restoration, 2. teeth that have received endodontic treatment and 3. teeth that have been extracted. Each tooth will be counted only once.
Time frame: 2 and 5 years after enrollment
Number of restored surfaces
The number of surfaces that have received a restoration.
Time frame: 2 and 5 years after enrollment
Number of restored teeth
The number of teeth that have received a restoration.
Time frame: 2 and 5 years after enrollment
Number of patients who have received a restoration
The number of patients who have received a restoration.
Time frame: 2 and 5 years after enrollment
Number of surfaces with caries lesions in ICDAS-subgroups
Detected in the study baseline examinations
Time frame: At the baseline examination
Number of teeth with caries lesion in ICDAS-subgroups
Detected in the study baseline examinations
Time frame: At the baseline examination
Number of patients according to maximal ICDAS-subgroup caries lesion
Detected in the study baseline examinations.
Time frame: At the baseline examination
Number of changes in restorative, endodontic and extraction treatment plan at surface-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of changes in restorative, endodontic and extraction treatment plan at tooth-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of changes in restorative, endodontic and extraction treatment plan at patient-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of changes in treatment plan at surface-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of changes in treatment plan at tooth-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of changes in treatment plan at patient-level
Change from visual-tactile examination to visual-tactile examination supplemented with bitewing examination. Will only studied in the arm visual-tactile caries examination and bitewing radiography.
Time frame: At the baseline examination
Number of teeth that have received endodontic treatment
The number of teeth that have received endodontic treatment. Each tooth will be counted only once.
Time frame: 2 and 5 years after enrollment
Number of teeth that have been extracted
The number of teeth that have have been extracted. Each tooth will be counted only once.
Time frame: 2 and 5 years after enrollment
Number of acute dental visits to dental clinics
Number of visits to acute dental treatment
Time frame: 2 and 5 years from enrollment
The number of visits to dental clinics
The number of visits to dental clinics will be recorded from electronic patient records
Time frame: 2 and 5 years after enrollment
The length of visits to dental clinics
The length of visits to dental clinics will be recorded from electronic patient records
Time frame: 2 and 5 years after enrollment
Non-invasive caries treatments
Caries treatments that are not invasive. For example oral hygiene instructions, diet instructions, application of topical fluoride
Time frame: 2 and 5 years from enrollment
Costs related to caries care
Among the costs for the patient are time expenditure, travelling expenses and patient fees. Among the costs for the society are facility and consumables costs, and salaries to dental personnel.
Time frame: 2 and 5 years after enrollment
Number of caries lesions indicated for restorative treatment
Indications for restorative treatment are a) caries lesions that are not cleanable due to undermining cavitation, b) symptomatic caries lesions, c) caries lesions that have caused so much tooth substance loss that the tooth no longer is in occlusion, d) caries lesions causing a significant aesthetic impairment and e) caries lesions that threaten tooth vitality.
Time frame: At the baseline examination
Number of teeth indicated for endodontic treatment
Endodontic treatment is indicated for caries lesions that have caused irreversible pulpitis or necrosis of the pulp.
Time frame: At the baseline examination
Number of teeth indicated for extraction
Extraction is indicated for caries lesions indicated for restorative treatment but can not be restored well (for example when the caries lesion extends so close to marginal bone that moisture control is impossible).
Time frame: At the baseline examination
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The trial is conducted in Finland and is subject to Regulation (EU) 2016/679 (GDPR) and Finnish data protection legislation. The dataset consists of detailed clinical, radiographic, and dental treatment information from a small, well-defined cohort of young adults in the PANIC study, linked to national and local patient registers. Given the granularity of the data, the limited study population, and registry linkage, the data carry a high risk of re-identification even after pseudonymization. Sharing such data would exceed the scope of participant consent and could not be reconciled with the GDPR principles of purpose limitation, data minimization, and confidentiality (Article 5). Requests for scientific collaboration may be considered case-by-case, subject to ethics review, a GDPR-compliant data processing agreement
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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