Comparison of Treatment Outcome of Pulpotomy With Versus Without Dental Operating Microscope in Carious Mature Permanent Teeth

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

The goal of this \[randomized clinical trial\] is to evaluate the treatment outcome by assessing clinical and radiographic outcomes.

The main question it aims to answer is

Do using dental operating microscope incorperated with pulpotomy procedure will have a different outcome when compare with without using.

Participants will be asked to have clinical and radiographic evaluation for evaluating the outcome every year after treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy patients aged at least 18 years old with deep or extremely deep carious lesions in mature permanent teeth diagnose with asymptomatic or symptomatic irreversible pulpitis. Diagnoses are confirmed using EPT and cold tests. Pulpal and periapical diagnoses are based on terminology from the American Association of Endodontists (AAE, 2013)20.

Teeth are restorable with direct composite restoration.

Disqualifiers

Teeth with subgingival caries and/or clinical attachment loss more than 3 mm and probing depth more than 4 mm.

Negative responses to pulp sensibility tests, presence of sinus tracts, swelling, non-restorable crowns, immature roots, or no pulp exposure following complete caries removal in case of pre-operative diagnosis as asymptomatic irreversible pulpitis.

Patients with systemic diseases involving bleeding disorders such as hemophilia, Von Willebrand disease, platelet disorders. And patients under taking all kind of anticoagulant and anti-platelet.

Teeth with pulpal obliteration.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dental operating microscope

    Device

    Incorperating the using of dental operating microscope into the pulpotomy procedure

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Additional using of dental operating microscope in the procedureExperimental treatment 1 intervention
Group B: Routine pulpotomyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Treatment outcome

Treatment outcomes will be classified as healed, healing, or failure based on clinical and radiographic evaluations. Healed: Cases presenting with no clinical symptoms and no evidence of a periapical lesion on radiographic examination. Healing: Cases presenting with no clinical symptoms and a reduction in the size of the periapical lesion on radiographic examination. Failure: Cases presenting with clinical symptoms and/or enlargement of the periapical lesion on radiographic examination.

Time frame
Yearly up to 10 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: