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Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Silver nanoparticle/Calcium hydroxide
Silver Nanoparticles in gel form
Calcium Hydroxide Intracanal medication
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
  • Non-pregnant females
  • Asymptomatic necrotic mandibular single rooted teeth.
  • Normal occlusal contact with the opposing teeth.
  • Patients accepting to participate in the study.

Exclusion Criteria:

  • Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
  • Pregnant women: Avoid radiation exposure, anesthesia, and medication.
  • If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
  • Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
  • Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
  • Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
  • No restorability: Hopeless tooth.
  • Vital teeth
  • Immature teeth
  • Radiographic evidence of external or internal root resorption.
  • Any criterion, not mentioned in the inclusion criteria

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

AgNP/Ca(OH)

AgNP

Ca(OH)

Arm Description

Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping

Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping

Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping

Outcomes

Primary Outcome Measures

Change in post-operative pain
Numerical (0-10)

Secondary Outcome Measures

Intracanal Bacterial count reduction
Quantification of Colony forming units per milliliter of agar medium (CFU/mL)
Number of analgesic tablets taken by the patient after endodontic treatment
Number

Full Information

First Posted
September 28, 2018
Last Updated
October 16, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03692286
Brief Title
Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp
Official Title
Assessment of Postoperative Pain After Using Silver Nanoparticles With and Without Calcium Hydroxide as an Intracanal Medication in Patients With Necrotic Pulp: (A Randomized Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
August 18, 2020 (Actual)
Study Completion Date
September 18, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)
Detailed Description
When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AgNP/Ca(OH)
Arm Type
Active Comparator
Arm Description
Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping
Arm Title
AgNP
Arm Type
Active Comparator
Arm Description
Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping
Arm Title
Ca(OH)
Arm Type
Active Comparator
Arm Description
Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping
Intervention Type
Combination Product
Intervention Name(s)
Silver nanoparticle/Calcium hydroxide
Intervention Description
Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
Intervention Type
Drug
Intervention Name(s)
Silver Nanoparticles in gel form
Intervention Description
Intracanal medication composed of silver nanoparticles in gel form
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide Intracanal medication
Intervention Description
Calcium hydroxide intracanal medication
Primary Outcome Measure Information:
Title
Change in post-operative pain
Description
Numerical (0-10)
Time Frame
Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours
Secondary Outcome Measure Information:
Title
Intracanal Bacterial count reduction
Description
Quantification of Colony forming units per milliliter of agar medium (CFU/mL)
Time Frame
1 week
Title
Number of analgesic tablets taken by the patient after endodontic treatment
Description
Number
Time Frame
Within 4 days after the first session and after 1 week from first treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are free from any physical or mental handicapping condition with no underlying systemic disease. Non-pregnant females Asymptomatic necrotic mandibular single rooted teeth. Normal occlusal contact with the opposing teeth. Patients accepting to participate in the study. Exclusion Criteria: Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate. Pregnant women: Avoid radiation exposure, anesthesia, and medication. If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows: Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain. Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy. No restorability: Hopeless tooth. Vital teeth Immature teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nermine Hassan, Msc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Manial
ZIP/Postal Code
11553
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data will be made available
IPD Sharing Time Frame
It will be available after finishing the study
IPD Sharing Access Criteria
It will be uploaded on a folder on google drive to be accessed through this link
IPD Sharing URL
https://drive.google.com/open?id=1rZXDbSgsneWDO4xGz8KGkklEHHw2YYIX
Citations:
PubMed Identifier
23657409
Citation
Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
Results Reference
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Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

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