Comparison of Postoperative Pain After Pulpotomy Performed 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 \[randomized clinical trials\] is to investigate the effect of using dental operating microscope incorperated in full pulpotomy procedure in mature carious posterior teeth.

The main questions it aims to answer are:

investigate postoperative pain levels.

investigate the quality of life of patient after treatment.

If there is a comparison group: Researchers will compare the pulpotomy procedure with and without using dental operating microscope.

Participants will will be asked to do

* Pain evaluation with numerical rating scale * OHIP 14 survey before and 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 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.

Posterior teeth with moderate or severe pain according to The NRS (Numeric Rating Scale) According to this scale, the level of pain is documented in the range of 0-10 numerically and verbally as no pain (0), mild pain, non-disruptive to routine activities (1-3), moderate pain that interferes with daily life but no need analgesics intake (4-6) and severe pain that significantly disrupts normal acitivities requiring analgesic intervention (7-10).

Teeth that response negatively to percussion and palpation tests.

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.

Patients who had taken analgesics or anti-inflammatory drugs within the previous 24 hours. If necessary, record how many and dose that taken.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Using dental operating microscope

    Device

    Using dental operating microscope additional to the procedure

Treatment groups

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

Trial outcomes

Primary outcomes

1

Post-operative pain

Patient will be asked to do a post-operative pain assessment by using numerical rating scale before and after treatment a 6hr, 24 hrs, 48 hrs, 72 hrs. Minimum is 0, Maximum is 10 Higher the score worsen the outcome.

Time frame
72 hrs after treatment

Secondary outcomes

1

Patient's quality of life assessment

Patient will be asked to do OHIP-14 survey before and after treatment Minimum is 14, Maximum is 70 Higher the score worsen the outcome.

Time frame
72 hrs after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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