RecruitingNot ApplicableNCT06944028

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

Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions (SELECT): A Randomized Controlled Trial in a Practice-Based Research Network


Sponsor

Karolinska Institutet

Enrollment

666 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 19 Years

Inclusion Criteria2

  • 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 Criteria10

  • 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

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Interventions

PROCEDURESelective 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.

PROCEDUREStepwise 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.


Locations(1)

Folktandvården Stockholm

Stockholm, Sweden

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NCT06944028


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