NCT05424796

Postoperative Pain Intensity After Pulpotomy

Completed Phase 4 Last updated 28 June 2022

What this trial tests

Phase 4 trial testing Physiological saline in Symptomatic Irreversible Pulpitis in 90 participants. Completed in 11 October 2021.

Timeline

15 February 2021

Primary endpoint
11 October 2021

11 October 2021

Quick facts

Lead sponsor	Cumhuriyet University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	15 February 2021
Primary completion	11 October 2021
Estimated completion	11 October 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Physiological saline — full drug profile →
• Hemostasis and cavity disinfection with NaOCl
• Hemostasis and cavity disinfection with KTP laser

Conditions studied

• Symptomatic Irreversible Pulpitis — all drugs for Symptomatic Irreversible Pulpitis →

Sponsor

Cumhuriyet University

Who can join

18 and older, any sex, with Symptomatic Irreversible Pulpitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of Potassium Titanyl Phosphate Laser and Sodium Hypochlorite on Postoperative Pain Intensity Following Pulpotomy in Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial.
   Ayhan M, Altunbaş D. · · 2023 · cited 2× · PMID 37092958 · DOI 10.1089/photob.2022.0152