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

NCT03692286 | Completed Phase 4 DMC

• 1 other identifier: ENDO18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Change in post-operative pain

  Numerical (0-10)

  Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours

Secondary Outcomes (2)

• Intracanal Bacterial count reduction

  1 week

• Number of analgesic tablets taken by the patient after endodontic treatment

  Within 4 days after the first session and after 1 week from first treatment session

Study Arms (3)

AgNP/Ca(OH)

ACTIVE COMPARATOR

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

AgNP

ACTIVE COMPARATOR

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

Ca(OH)

ACTIVE COMPARATOR

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

Drug: Calcium Hydroxide Intracanal medication

Interventions

Silver nanoparticle/Calcium hydroxide COMBINATION_PRODUCT

Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide

AgNP/Ca(OH)

Silver Nanoparticles in gel form DRUG

Intracanal medication composed of silver nanoparticles in gel form

AgNP

Calcium Hydroxide Intracanal medication DRUG

Calcium hydroxide intracanal medication

Ca(OH)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, 11553, Egypt

Location

Related Publications (1)

• 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.

  PMID: 23657409 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Calcium Hydroxide; colloidal silver

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Nermine Hassan, Msc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Endodontics

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: June 1, 2019
• Primary Completion: August 18, 2020
• Study Completion: September 18, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: It will be available after finishing the study
• Access Criteria: It will be uploaded on a folder on google drive to be accessed through this link

Locations

EG (1)