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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03724266
• Other study ID #: ahmed abdelmonam
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healing
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Chitosan
chitosan will be used as intracanal medication
• Calcium Hydroxide
intracanal medication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in healing of apical periodontitis	linear measurment of apical radiolucency using cone beam computed tomography	3,6,12 months