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

NCT06944028 | Recruiting

• 3 other identifiers: Dnr 2024-03717-01selective excavationSELECT
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Dental Cavities

Keywords

SELECT; stepwise excavation; selective excavation; deep dental caries lesions; young permanent teeeth

Outcome Measures

Primary Outcomes (1)

• Sustained tooth vitality

  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.

  1-1,5 years after baseline

Secondary Outcomes (5)

• Health economic

  Up to 3 years (after baseline)

• Quality of life (Qol)

  1 -1,5 years after baseline

• No pain from tooth

  1-1,5 years after baseline

• Sustained tooth without root canal treatment

  Up to 3 years (after baseline)

• Tooth survival

  Up to 3 years (after baseline)

Study Arms (2)

Selective excavation

EXPERIMENTAL

One visit procedure

Procedure: Selective excavation

Stepwise excavation-two visit procedure

ACTIVE COMPARATOR

Two-visit procedure

Procedure: Stepwise excavation

Interventions

Selective excavation PROCEDURE

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.

Selective excavation

Stepwise excavation PROCEDURE

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.

Stepwise excavation-two visit procedure

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Folktandvården Stockholms län AB: collaborator
• Praktikertjanst AB: collaborator

Study Sites (1)

Folktandvården Stockholm

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Maria Anderson, PhD

CONTACT

+46812316538; maria.anderson@regionstockholm.se

Georgios Tsilingaridis, Associate professor

CONTACT

+46852488029; georgios.tsilingaridis@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: April 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-04

Locations

SE (1)