Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing

Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Healing
• Intervention / Treatment: Drug: Chitosan; Drug: Calcium Hydroxide

Detailed Description

PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).

I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.

O (outcome):

Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours

Secondary outcome:

1. Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months
2. Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.
3. healing of apical periodontitis using CBCT at 3, 6, 12 months

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients in good general health.
• Patient's age ranging between 20-40 years with no sex predilection.
• Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
• Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
• Patients' acceptance to participate in the study.

Exclusion criteria:

• Medically compromised patients with a severe systemic condition.
• Pregnant female patients.
• Patients who had taken any antibiotic or analgesics during the past 24 hours.
• Presence of a swelling because emergency management may include incision and drainage.
• Retreatment cases.
• Generalized periodontitis (calculus, deep pockets).
• Out of normal variations (open apex- severely curved canal- obstructed canal).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chitosan; chitosan as intracanal medication 0.2% in form of gel	Drug: Chitosan; chitosan will be used as intracanal medication
Active Comparator: calcium hydroxide; intracanal medication	Drug: Calcium Hydroxide; intracanal medication; Other Names: CaOH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in postoperative pain after intervention of chitosan: NRS	pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours	4,12,24,27 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in healing of apical periodontitis	linear measurment of apical radiolucency using cone beam computed tomography	3,6,12 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Calcium-Regulating Hormones and Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Calcium; Chitosan
• Other Study ID Numbers: ahmed abdelmonam

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No