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

NCT ID: NCT03724266

Last Updated: 2018-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-12-31

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:

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

Conditions

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Postoperative Pain Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

postoperative pain after intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
participants should be blinded

Study Groups

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chitosan

chitosan as intracanal medication 0.2% in form of gel

Group Type EXPERIMENTAL

Chitosan

Intervention Type DRUG

chitosan will be used as intracanal medication

calcium hydroxide

intracanal medication

Group Type ACTIVE_COMPARATOR

Calcium Hydroxide

Intervention Type DRUG

intracanal medication

Interventions

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Chitosan

chitosan will be used as intracanal medication

Intervention Type DRUG

Calcium Hydroxide

intracanal medication

Intervention Type DRUG

Other Intervention Names

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CaOH

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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ahmed abdelmonam abd elmougoud

Phd student, principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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ahmed abdelmonam

Identifier Type: -

Identifier Source: org_study_id

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