Postoperative Pain Intensity After Pulpotomy

June 27, 2022 updated by: Muhammed Ayhan, Cumhuriyet University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sivas/Merkez
      • Sivas, Sivas/Merkez, Turkey
        • Sivas Cumhuriyet University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Physiological saline (Control group) (n=30)
In this group, hemostasis was achieved by checking the saline soaked cotton pellet placed over canal orifices and into the pulp chamber at 2-minute intervals.
Combination product: Physiological saline
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.
Experimental: Group 2: Hemostasis and cavity disinfection with NaOCl (n=30)
In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis.
Combination product: Hemostasis and cavity disinfection with NaOCl
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.
Experimental: Group 3: Hemostasis and cavity disinfection with KTP laser (n=30)
In this group, complete hemostasis and cavity disinfection were achieved using a KTP laser (SMARLITE D, Deka, Calenzano FI, Italy). After initial hemorrhage control, complete hemostasis was achieved by exposure to a KTP laser (532 nm wavelength) in noncontact mode at 1.5 W of power with a pulse mode (Ton 100 ms, Toff 100 ms) for 2 s. The diameter of optical fiber was 300 μm. Laser application was repeated 3 times if required. After bleeding control was achieved, cavity disinfection was performed by laser application with a noncontact circular movement for 5 s using 1 W power and 300 nm tip.
Device: Hemostasis and cavity disinfection with KTP laser
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 7 and 30 days after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cumhuriyet University

Investigators

  • Study Director: Demet Altunbaş, DDS, PhD, Cumhuriyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

October 11, 2021

Study Completion (Actual)

October 11, 2021

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cumhuriyet-University-M-AYHAN-

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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