RecruitingNCT05816525

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


Sponsor

University of Helsinki

Enrollment

100 participants

Start Date

Apr 21, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether symptoms of tooth pain before dental treatment can predict outcomes after partial removal of decayed tissue from a tooth — a technique used to preserve the tooth's living pulp rather than performing a root canal. This approach, called stepwise or partial caries excavation, is increasingly preferred when decay is deep but the pulp is still healthy, but clinicians have limited evidence on which teeth will do well versus which will ultimately need root canal treatment. Eligible participants are Finnish- or English-speaking adults aged 18 to 50 with a deep cavity in a premolar or molar that shows signs of mild pulpitis or no symptoms at all, with a pulp that still responds to testing. Numerous exclusions apply, including pregnancy, serious medical conditions, prior major fillings, periapical changes on X-ray, or signs of irreversible pulp damage. Participants receive partial caries removal and are followed at multiple intervals to track whether the tooth remains healthy or progresses to need root canal treatment. Root canal procedures are costly, time-consuming, and weaken the tooth structure. If this research identifies clinical predictors of treatment success, dentists can more confidently offer pulp-preserving approaches to appropriate patients — reducing unnecessary root canals and improving long-term tooth survival.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPartial 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.

PROCEDUREFinal 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.


Locations(1)

Western Uusimaa Wellbeing Services County

Espoo, Finland

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NCT05816525


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