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

Not Applicable

• Conditions: Postoperative Pain; Healing
• Interventions: Drug: Chitosan; Drug: Calcium Hydroxide

• Registration Number: NCT03724266
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Status Verified: 2018-10
• Study Start: 2018-10
• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chitosan	Chitosan	chitosan as intracanal medication 0.2% in form of gel
calcium hydroxide	Calcium Hydroxide	intracanal medication

Primary Outcome Measures

Name	Time	Method
change in postoperative pain after intervention of chitosan: NRS	4,12,24,27 hours	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

Secondary Outcome Measures

Name	Time	Method
change in healing of apical periodontitis	3,6,12 months	linear measurment of apical radiolucency using cone beam computed tomography