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Enrolling By Invitation
NCT06944028
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Conditions: Dental Caries, Dental Cavities
Sex: All
Ages: 8 Years – 19 Years
Healthy volunteers: No
Phase: NA
Enrollment: 666
Sponsor: Karolinska Institutet
Location: Folktandvården Stockholm Stockholm
Summary
The purpose of this clinical trial is to evaluate and compare the outcomes of selective carious tissue removal versus stepwise carious tissue removal in young permanent teeth with deep carious lesions. The primary follow-up will be conducted 1 year after treatment to assess success. A secondary follow-up will take place 3 years post-treatment, utilizing data from dental registries and dental records. The study is a randomized controlled trial conducted within a practice-based research network.
Eligibility Criteria
Inclusion Criteria:
Children aged 8- 19 years (last December the year they turn 19 years) A fully erupted molar or pre-molar teeth with dental caries (class I or class II) extending to more than 2/3 of the dentine thickness (and on the bitewing radiograph showing a radiodense zone separating the pulp from the demineralized dentine).
Bitewing radiograph has been taken as part of the ordinary dental examination Available for recall at least for 1 year.
Exclusion Criteria:
Extraction is planned of the tooth with deep caries in the future with expected spontaneous gap closure.
If the carious tooth shows sign or symptoms of irreversible pulp pathology or loss of vitality including:
* Presence of a sinus tract (fistula)
* Tenderness to percussion
* Buccal tenderness
* Severe sensitivity
* Evidence of pathology on a periapical radiograph (if radiograph is clinically justified and performed)
* No written informed consent.
* Medical condition requiring special considerations with regard of the dental management
* Dental treatment cannot be performed adequate due to lack cooperation
Source: ClinicalTrials.gov (NCT06944028). StuddyBuddy aggregates publicly available trial information.