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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 18, 2020

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.

Interventions

  • Combination Product: Silver nanoparticle/Calcium hydroxide
    • Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
  • Drug: Silver Nanoparticles in gel form
    • Intracanal medication composed of silver nanoparticles in gel form
  • Drug: Calcium Hydroxide Intracanal medication
    • Calcium hydroxide intracanal medication

Arms, Groups and Cohorts

  • Active Comparator: AgNP/Ca(OH)
    • Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping
  • Active Comparator: AgNP
    • Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping
  • Active Comparator: Ca(OH)
    • Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nermine Elsayed Abdelsalam Hassan, Assistant Lecturer of Endodontics – Cairo University
  • Overall Official(s)
    • Nermine Hassan, Msc, Principal Investigator, Cairo University

References

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.

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