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Enrolling by invitation Not applicable

Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.

NCT06944028 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2025-09-01
Last updated
2026-08-12

Condition(s) studied

Dental CariesDental Cavities

Investigational drug(s) / intervention(s)

Selective excavationStepwise excavation

Selective excavation: Partial removal of carious dentine, soft carious tissue is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, and a permanent restoration is placed on the tooth.

Stepwise excavation: Partial removal of carious dentine is performed, soft dentine is intentionally left over the pulp to avoid exposure. The peripheral enamel and dentine are prepared to hard dentine, application of a provisional restoration. After approximately 3-5 months, the provisional restoration is removed, and any remaining carious dentine is further removed until firm dentine is reached. A permanent restoration is then applied.

Study 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

Sex
ALL
Min age
8 Years
Max age
19 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Sustained tooth vitality — 1-1,5 years after baseline
    The examining dentist will aggregate a combination of clinical tests and radiographic findings that need to be fulfilled, to assess the outcome: sustained tooth vitality. All assessments will be recorded separately. The following measures will be recorded: positive response to cold test, absence of fistula or abscess, absence of tenderness on percussion, no evidence of pulp necrosis based on a periapical radiograph (if clinically justified and performed), no root filling. Additionally, the examining dentist will document which tests have been performed to justify the assessment.

Trial sites (1)

FacilityCityRegionStatus
Folktandvården Stockholm Stockholm Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06944028 on ClinicalTrials.gov ↗ ← All trials in Sweden