Clinical trial NCT03692286: Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in post-operative pain
timeFrame: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours
Secondary outcomes:
measure: Intracanal Bacterial count reduction
timeFrame: 1 week
measure: Number of analgesic tablets taken by the patient after endodontic treatment
timeFrame: Within 4 days after the first session and after 1 week from first treatment session
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Nermine Hassan, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.