Impact of Symptoms and Lesion Depth on Partial Carious Tissue Removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate how preoperative symptoms and the depth of carious lesions influence the outcomes of partial removal of carious tissue in mature teeth of adults. One hundred participants will be recruited, and their symptoms will be assessed through a questionnaire seven days post-treatment. The study will follow the participants for 12 to 24 months to monitor the effectiveness of the treatment. The research is grounded in Finnish national treatment guidelines for vital teeth with deep carious lesions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* the patient is communicating in the Finnish or English language
* a deep primary or secondary carious lesion in 1st or 2nd premolar or molar on occlusal or proximal surface, extending to the deepest quarter of dentine assessed from the radiograph
* asymptomatic or symptoms not more severe than reversible pulpitis (mild pulpitis according to the new pulpitis classification proposal)
* pulp responding to the electric pulp testing and cold testing
* the periodontal stage of the tooth should be I or II.

In case the patient has several teeth fulfilling the inclusion criteria, the one with the deepest lesion and/or most severe symptoms is chosen to the study.

Exclusion Criteria:

* general medical condition which makes the patient more susceptible to odontogenic infection complications
* pregnancy, breastfeeding
* mental retardation, memory disorder
* the carious lesion is extending to more than three surfaces or to both proximal surfaces
* the tooth has previous other filling(s): i) extending deeper than to the outer third of dentine; or ii) the filling is larger than Class I or II; or iii) Class II filling is not restricted to enamel; or iv) the filling has secondary/residual caries
* the tooth is not restorable
* periapical changes in the periapical radiograph
* sensitivity to percussion; swelling; sinus tract; increased mobility; resorption
* furcal lesion more severe than Class I
* ongoing orthodontic treatment
* declining to sign the written consent.

Where it's running

• Western Uusimaa Wellbeing Services County
  Espoo, Finland Recruiting

Study contacts

• Study coordinator: Katri Croft, DDS
• Email: katri.croft@helsinki.fi
• Phone: +358407367250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.