Postoperative Pain, Healing
Conditions
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
Interventions
DRUGChitosan
chitosan will be used as intracanal medication
DRUGCalcium Hydroxide
intracanal medication
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participants should be blinded
Intervention model description
postoperative pain after intervention
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| change in healing of apical periodontitis | 3,6,12 months | linear measurment of apical radiolucency using cone beam computed tomography |
Outcome results
None listed