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

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)

To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Combination product: Silver nanoparticle/Calcium hydroxide; Drug: Silver Nanoparticles in gel form; Drug: Calcium Hydroxide Intracanal medication

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 11553
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AgNP/Ca(OH); Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping	Combination product: Silver nanoparticle/Calcium hydroxide; Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
ACTIVE_COMPARATOR: AgNP; Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping	Drug: Silver Nanoparticles in gel form; Intracanal medication composed of silver nanoparticles in gel form
ACTIVE_COMPARATOR: Ca(OH); Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping	Drug: Calcium Hydroxide Intracanal medication; Calcium hydroxide intracanal medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in post-operative pain	Numerical (0-10)	Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracanal Bacterial count reduction	Quantification of Colony forming units per milliliter of agar medium (CFU/mL)	1 week
Number of analgesic tablets taken by the patient after endodontic treatment	Number	Within 4 days after the first session and after 1 week from first treatment session

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nermine Hassan, Msc, Cairo University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): August 18, 2020
• Study Completion (ACTUAL): September 18, 2020

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Dental Pulp Necrosis; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium; Calcium, Dietary
• Other Study ID Numbers: ENDO18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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