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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03724266
Collaborator
(none)
60
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
postoperative pain after interventionpostoperative pain after intervention
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
participants should be blinded
Primary Purpose:
Treatment
Official Title:
Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: chitosan

chitosan as intracanal medication 0.2% in form of gel

Drug: Chitosan
chitosan will be used as intracanal medication
Active Comparator: calcium hydroxide

intracanal medication

Drug: Calcium Hydroxide
intracanal medication
Other Names:
  • CaOH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. change in healing of apical periodontitis [3,6,12 months]

      linear measurment of apical radiolucency using cone beam computed tomography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ahmed abdelmonam abd elmougoud, Phd student, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03724266
    Other Study ID Numbers:
    • ahmed abdelmonam
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Nov 1, 2018
    Last Verified:
    Oct 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Chitosan
    Calcium

    Study Results

    No Results Posted as of Nov 1, 2018