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

Postoperative Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692286
• Other study ID #: ENDO18
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: September 18, 2020

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 18, 2020
• Est. primary completion date: August 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Pain, Postoperative
• Postoperative Pain

Intervention

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
• Calcium Hydroxide Intracanal medication
Calcium hydroxide intracanal medication

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-operative pain	Numerical (0-10)	Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours
Secondary	Intracanal Bacterial count reduction	Quantification of Colony forming units per milliliter of agar medium (CFU/mL)	1 week
Secondary	Number of analgesic tablets taken by the patient after endodontic treatment	Number	Within 4 days after the first session and after 1 week from first treatment session