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

Cairo University60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain Healing

Interventions

ChitosanDRUG

chitosan will be used as intracanal medication

Calcium HydroxideDRUG

intracanal medication

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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

Time frame: 4,12,24,27 hours

Secondary Outcomes

change in healing of apical periodontitis

linear measurment of apical radiolucency using cone beam computed tomography

Time frame: 3,6,12 months

Data from ClinicalTrials.gov

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