NCT05816525

The Prognostic Impact of Symptoms and Lesion Depth in Partial Removal of Carious Tissue

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The goal of this prospective, observational clinical cohort study is to study the effect of the preoperative condition of the tooth on the outcome of partial removal of carious tissue in mature teeth in adults. The main questions the study aims to answer are: * Do preoperative symptoms affect the outcome? * Does the depth of the carious lesion affect the outcome? One hundred participants will be recruited. Patients who meet the eligibility criteria will be asked to give their informed consent to participate in the study. Partial carious tissue removal will be performed regardless of participation in the study because selective carious tissue removal is the standard treatment of choice for a vital tooth with a deep carious lesion according to the Finnish national treatment guidelines. Participants will be asked to fill in a questionnaire regarding symptoms 7 days post-treatment. The teeth will then be followed up for 12-24 months. The null hypothesis is that there is no difference in the success between i) deep and extremely deep carious lesions and ii) initial and mild pulpitis.

Conditions

• Deep Caries
• Pulpitis Reversible
• Pulp Hyperemia

Interventions

Type	Name	Description
PROCEDURE	Partial removal of carious tissue	Nonselective carious tissue excavation will be performed in the periphery of the cavity to achieve a good marginal seal. In the pulpal wall selective, partial carious tissue excavation is performed to the soft dentin, removing tissue only the amount that is necessary for placing the restoration. The tooth is restored with high-viscosity glass-ionomer cement.
PROCEDURE	Final restoration	The teeth will be restored with composite resin after 12 months follow up, if the tooth is asymptomatic, responds to sensibility tests and there are no periapical changes radiographically. Glass ionomer cement will be only partially removed to create space for the final restoration.

Timeline

• Start date: 2023-04-21
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-04-18
• Last updated: 2025-04-03

Locations

1 site across 1 country: Finland