Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.
NCT ID: NCT05582421
Last Updated: 2022-11-10
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
30 participants
INTERVENTIONAL
2022-12-31
2024-08-31
Brief Summary
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Detailed Description
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\- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.
Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
* The patients who already do not know their treatment group will assess the level of their post-operative pain.
* The laboratory technician at the microbiological department will not know the treatment group of the patients.
* The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
Study Groups
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calcium hydroxide
calcium hydroxide will be placed as intracanal medication between visits.
Diclofenac Sodium
intracanal medication
diclofenac sodium
diclofenac sodium will be placed as intracanal medication between visits
Diclofenac Sodium
intracanal medication
Interventions
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Diclofenac Sodium
intracanal medication
Eligibility Criteria
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Inclusion Criteria
* Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Age between 18-50 years.
* Males \& Females.
* Mandibular single rooted permanent premolar teeth:
* Diagnosed clinically with pulp necrosis.
* Absence of spontaneous pain.
* Positive pain on percussion denoting apical periodontitis.
* Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria
* Pregnant women.
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth that show association with acute periapical abscess and swelling.
* Greater than grade I mobility or pocket depth greater than 5mm.
* Non-restorable teeth
* Teeth with vital pulp.
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
18 Years
50 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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mohammed awadd
assistant lecturer
Other Identifiers
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1141821228
Identifier Type: -
Identifier Source: org_study_id
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