Skip to main content
OpenTrials
Completed

NCT Number: NCT05424796

Postoperative Pain Intensity After Pulpotomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Symptomatic Irreversible Pulpitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sivas Cumhuriyet University

Sivas, Sivas/Merkez, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiological saline

Combination Product

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, hemostasis was achieved by checking the saline soaked cotton pellet.

Hemostasis and cavity disinfection with NaOCl

Combination Product

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices.

Hemostasis and cavity disinfection with KTP laser

Device

Pulpotomy is a vital pulp treatment in which the vital coronal pulp tissue is surgically removed and the remaining radicular dental pulp is covered with an appropriate material. In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy).

Primary outcomes

  1. 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.

    Time frame: Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.

    The preoperative pain values of the patient were marked on the visual analog scale by the patient. The intensity of the pain was calculated by measuring the area in which the individual was marked between 0 (no pain) and 100 (worst pain). Patients recorded postoperative pain levels on the VAS for pain from 0 (no pain) to 100 (worst pain) at 6, 24, and 48 hours, and 7 and 30 days after treatment.

Secondary outcomes

  1. Change from baseline in percussion values on the visual analog scale (VAS) at 7 and 30 days after treatment.

    Time frame: Baseline and at 7 and 30 days after treatment.

    The preoperative percussion values of the patient were marked on the visual analog scale by the patient. The intensity of the percussion was calculated by measuring the area in which the individual was marked between 0 (no pain) and 100 (severe pain). Patients recorded postoperative percussion levels on the VAS for pain from 0 (no pain) to 100 (worst pain) at 7 and 30 days after treatment.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

Postoperative Pain Intensity Following Pulpotomy With Different Disinfection and Hemostatic Procedures in Teeth With Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.