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Completed

NCT Number: NCT03692286

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

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

Completed

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Manial, 11553, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver nanoparticle/Calcium hydroxide

Combination Product

Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide

Silver Nanoparticles in gel form

Drug

Intracanal medication composed of silver nanoparticles in gel form

Calcium Hydroxide Intracanal medication

Drug

Calcium hydroxide intracanal medication

Primary outcomes

  1. Change in post-operative pain

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

    Numerical (0-10)

Secondary outcomes

  1. Intracanal Bacterial count reduction

    Time frame: 1 week

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

  2. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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