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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2027
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v5
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2024v4
  4. Eligibility criteria expanded, about 9 wordsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 20, 2023 to Apr 21, 2023
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05816525
Lead Sponsor University of Helsinki
Conditions
(from sponsor)		 Deep Caries, Pulpitis Reversible, Pulp Hyperemia
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov