search
Back to results

Postoperative Pain Intensity After Pulpotomy

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Physiological saline
Hemostasis and cavity disinfection with NaOCl
Hemostasis and cavity disinfection with KTP laser
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis focused on measuring Irreversible pulpitis, KTP laser, mineral trioxide aggregate, postoperative pain, pulpotomy, visual analog scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sivas Cumhuriyet University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: Physiological saline (Control group) (n=30)

Group 2: Hemostasis and cavity disinfection with NaOCl (n=30)

Group 3: Hemostasis and cavity disinfection with KTP laser (n=30)

Arm Description

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.

In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis.

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.

Outcomes

Primary Outcome Measures

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.
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 Outcome Measures

Change from baseline in percussion values on the visual analog scale (VAS) 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.

Full Information

First Posted
June 15, 2022
Last Updated
June 27, 2022
Sponsor
Cumhuriyet University
search

1. Study Identification

Unique Protocol Identification Number
NCT05424796
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
October 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Irreversible pulpitis, KTP laser, mineral trioxide aggregate, postoperative pain, pulpotomy, visual analog scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Physiological saline (Control group) (n=30)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Hemostasis and cavity disinfection with NaOCl (n=30)
Arm Type
Experimental
Arm Description
In this group, 2.5% NaOCl soaked cotton pellets were placed over canal orifices and into the pulp chamber to achieve complete hemostasis.
Arm Title
Group 3: Hemostasis and cavity disinfection with KTP laser (n=30)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Physiological saline
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Hemostasis and cavity disinfection with NaOCl
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hemostasis and cavity disinfection with KTP laser
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline and at 6, 24, 48 and 72 hours, and 7 and 30 days after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline in percussion values on the visual analog scale (VAS) at 7 and 30 days after treatment.
Description
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.
Time Frame
Baseline and at 7 and 30 days after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demet Altunbaş, DDS, PhD
Organizational Affiliation
Cumhuriyet University
Official's Role
Study Director
Facility Information:
Facility Name
Sivas Cumhuriyet University
City
Sivas
State/Province
Sivas/Merkez
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Postoperative Pain Intensity After Pulpotomy

We'll reach out to this number within 24 hrs