Back to resultsEffect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
Primary Purpose
Postoperative Pain, Healing
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chitosan
Calcium Hydroxide
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chitosan
calcium hydroxide
Arm Description
chitosan as intracanal medication 0.2% in form of gel
intracanal medication
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
change in healing of apical periodontitis
linear measurment of apical radiolucency using cone beam computed tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03724266
Brief Title
Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
Official Title
Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
postoperative pain after intervention
Masking
ParticipantOutcomes Assessor
Masking Description
participants should be blinded
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chitosan
Arm Type
Experimental
Arm Description
chitosan as intracanal medication 0.2% in form of gel
Arm Title
calcium hydroxide
Arm Type
Active Comparator
Arm Description
intracanal medication
Intervention Type
Drug
Intervention Name(s)
Chitosan
Intervention Description
chitosan will be used as intracanal medication
Intervention Type
Drug
Intervention Name(s)
Calcium Hydroxide
Other Intervention Name(s)
CaOH
Intervention Description
intracanal medication
Primary Outcome Measure Information:
Title
change in postoperative pain after intervention of chitosan: NRS
Description
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
Time Frame
4,12,24,27 hours
Secondary Outcome Measure Information:
Title
change in healing of apical periodontitis
Description
linear measurment of apical radiolucency using cone beam computed tomography
Time Frame
3,6,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
12. IPD Sharing Statement
Learn more about this trial
Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
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