Clinical trial NCT05424796: Postoperative Pain Intensity After Pulpotomy
Official title: Postoperative Pain Intensity Following Pulpotomy With Different Disinfection and Hemostatic Procedures in Teeth With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Symptomatic Irreversible Pulpitis
Keywords: Irreversible pulpitis
KTP laser
mineral trioxide aggregate
postoperative pain
pulpotomy
visual analog scale
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: This study aimed to compare postoperative pain rates following sodium hypochlorite (NaOCl) and KTP laser-assisted pulpotomy treatments in permanent teeth with deep caries, and symptomatic irreversible pulpitis. Methods: Ninety patients complaining of permanent teeth pain due to symptomatic irreversible pulpitis were randomly divided into 3 equal groups. Preoperative pain levels were recorded. After the initial bleeding control was achieved with saline, complete hemostasis was achieved by applying saline (control group), 2.5% NaOCl, or KTP laser according to randomly determined patient groups. Patients were asked to mark their pain level on the visual pain scale at the 6th, 24th, 48th, and 72nd hours, and 7th and 30th days depending on the severity of the pain. The permanent restoration was completed after 7 days. Results: According to the present study, the statistical difference between the groups in terms of preoperative pain and percussion pain levels was insignificant.

There was no significant difference between the groups in terms of demographic data. The postoperative pain level of the KTP laser group was significantly lower at the 6th hour compared to the saline group. There was no significant difference between the groups in terms of postoperative pain level at other time intervals. The greatest pain scores occurred in all groups at 6th hour. Conclusions: KTP laser can be preferred primarily in reducing postoperative pain in pulpotomy treatments. KTP laser or NaOCl assisted pulpotomy can be an effective treatment for pain reduction in permanent teeth with symptomatic irreversible pulpitis.


Eligibility criteria: Inclusion Criteria:

* The patient should be ≥ 18 years old, a single tooth in every patient
* Must be signs of irreversible pulpitis, such as persistent pain that begins spontaneously and/or is exacerbated by cold. This situation should be repeated with the cold test.
* Irreversible pulpitis diagnosed, with or without symptomatic apical periodontitis
* No systemic disease
* Should give a positive response to electrical and thermal tests
* Must be the opposite tooth.
* The tooth is restorable, probing pocket (3mm) depth, and mobility are within normal limits

Exclusion Criteria:

* Presence of allergies
* Using analgesics in the last 12 hours or antibiotics in the last 1 week before the procedure.
* Presence of swelling, palpation pain or sinus tract before treatment, root fracture or crack.
* Failure to control bleeding within 6 minutes,
* Presence of bruxism or open apex.
* Insufficient bleeding after pulp exposure
* Observation of advanced canal calcification
* Presence of internal or external root resorption.

Primary outcomes:
measure: Change from baseline in pain intensity on the visual analog scale (VAS) at 6, 24, 48, and 72 hours, and 7 and 30 days after treatment.
timeFrame: Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.
Secondary outcomes:
measure: Change from baseline in percussion values on the visual analog scale (VAS) at 7 and 30 days after treatment.
timeFrame: Baseline and at 7 and 30 days after treatment.
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
state: Sivas/Merkez
Study officials:
affiliation: Cumhuriyet University
name: Demet Altunbaş, DDS, PhD
role: STUDY_DIRECTOR
References: