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

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

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

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

Conditions
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Postoperative Pain, Healing

Intervention / Treatment
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* Drug: Chitosan
* Drug: Calcium Hydroxide


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: postoperative pain after intervention
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |