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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Nermine Elsayed Abdelsalam Hassan，Cairo University

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

May 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in post-operative pain[ Time Frame: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours ]

Numerical (0-10)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

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
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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 18, 2019

Estimated Primary Completion Date

May 18, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

Nermine Elsayed Abdelsalam Hassan，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Nermine Hassan, Msc Cairo University

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名