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CompletedNCT03692286Updated Oct 19, 2020

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

A Phase 4 interventional study of Silver nanoparticle/Calcium hydroxide and Silver Nanoparticles in gel form in Postoperative Pain, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Postoperative Pain
03

In context

Dental Pulp Necrosis

149 studies on the registry are indexed under Dental Pulp Necrosis; 39 are open to participants now.

This study's enrollment of 30 is below the median of 44 across 139 interventional studies indexed under Dental Pulp Necrosis.

Browse Dental Pulp Necrosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

  • Active comparator
    Ca(OH)

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

    Drug: Calcium Hydroxide Intracanal medication

Interventions

  • Combination productSilver nanoparticle/Calcium hydroxide

    Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide

  • DrugSilver Nanoparticles in gel form

    Intracanal medication composed of silver nanoparticles in gel form

  • DrugCalcium Hydroxide Intracanal medication

    Calcium hydroxide intracanal medication

06

What researchers measure

Primary outcomes

  1. Change in post-operative pain

    Numerical (0-10)

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

Secondary outcomes

  1. Intracanal Bacterial count reduction

    Quantification of Colony forming units per milliliter of agar medium (CFU/mL)

    Time frame: 1 week

  2. Number of analgesic tablets taken by the patient after endodontic treatment

    Number

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

07

Study locations

1 site
  • Cairo University
    Cairo, Manial 11553, Egypt
08

References and documents

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. PubMed 23657409 ↗

Individual participant data

Plan to share: Yes — Participant data will be made available

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03692286
Lead sponsor
Cairo University
Responsible party
Nermine Elsayed Abdelsalam Hassan (Assistant Lecturer of Endodontics, Cairo University) — Principal investigator
First posted
Oct 2, 2018
Start date
Jun 1, 2019
Primary completion
Aug 18, 2020
Completion
Sep 18, 2020
Last update
Oct 19, 2020

Study contacts

Nermine Hassan, Msc
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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