Impact of Symptoms and Lesion Depth on Partial Carious Tissue Removal

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

This study is trying to see how symptoms and the depth of tooth decay affect the success of removing part of the decayed tissue in adult teeth.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Helsinki (other)
• Locations: 1 site (Espoo)
• Trial ID: NCT05816525 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with deep carious lesions in their premolars or molars who exhibit mild symptoms of reversible pulpitis.

Not a fit: Patients with severe symptoms, extensive carious lesions, or underlying medical conditions that increase infection risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment strategies for deep carious lesions, leading to better patient outcomes.

How similar studies have performed: While similar studies have explored the effects of carious tissue removal, this specific approach focusing on symptom and lesion depth is relatively novel.

Eligibility criteria

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 this trial is running

Espoo

• Western Uusimaa Wellbeing Services County — Espoo, Finland (RECRUITING)

Study contacts

• Study coordinator: Katri Croft, DDS

Conditions: Deep Caries, Pulpitis Reversible, Pulp Hyperemia, vital pulp therapy, deep carious lesion, selective carious tissue removal