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The goal of this randomized clinical trial is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis.
The main question[s] it aims to answer are:
• Will the diclofenac sodium (NSAIDs) possess antimicrobial efficacy to be used effectively as an intracanal medicament similar to that of calcium hydroxide in primary endodontic treatment? Participants will be allocated randomly into three equal groups by using computer generated randomization, according to the type of intracanal medication.
The aim of the present study is to evaluate the capability of the material to exert bacterial reduction of diclofenac sodium versus of that calcium hydroxide paste when these materials are used as intracanal medications in permanent molar teeth with chronic apical periodontitis. The evaluation is to be done using quantitative microbiological assessment from samples extracted from root canals before and after intracanal medicament placement in roots of permanent molars, having PAI score ≥ 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High concentration of diclofenac sodium | Experimental | High concentration of diclofenac sodium mixed with saline |
|
| Low concentration of diclofenac sodium | Active Comparator | Low concentration of diclofenac sodium mixed with saline |
|
| Calcium hydroxide | Active Comparator | Calcium hydroxide paste form |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Sodium | Drug | placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial count | Variation in bacterial count in high concentration of Diclofenac Sodium group compared by group of low concentration of Diclofenac Sodium group and calcium hydroxide group. | On the seventh day from of intracanal medication placement appointment |
| Measure | Description | Time Frame |
|---|---|---|
| Periapical healing | Change in the size of periapical lesion (according to Periapical index scale). The participants will be recalled after at least 6 months, and radiographic examination of the treated tooth will be performed. Preoperative and recall radiographs of teeth will be each assigned a Periapical index score by 2 blinded, independent, and calibrated examiners according to periapical index score (PAI): PAI 1: Normal periapical structure. PAI 2: Bone structural changes indicating but not pathognomonic for apical periodontitis. PAI 3: Bone structural changes with some mineral loss characteristic for apical periodontitis. PAI 4: Well-defined apical radiolucency. PAI 5: Radiolucency with radiating expansion of bone structural changes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Summer M Elsayed, Bachelor | Contact | 01000095124 | pg.summer92140015@bue.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Shehab Eldin M Saber, doctoral | british university in Egypt- dentistry collage | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British university in Egypt | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D002126 | Calcium Hydroxide |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Calcium hydroxide | Drug | placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. |
|
| participants will be recalled after 6 months from the obturation for radiographic examination. |
| incidence and intensity of pain | Patient will receive visual analogue scale (VAS) that will include a 10 cm line in which number 0 will correspond to no pain and number 10 will indicate unacceptable pain. Evaluation of intensity and incidence of pain, will be assessed each day for the following first three days after intracanal placement appointment (after 24 hours, 48 hours and 72 hours). | Pain intensity will be assessed at 24 hours, 48 hours and 72 hours following initial treatment using a visual analogue scale |
| Incidence of flare-ups | Flare-up will be defined to patients as the development of swelling after treatment and will be represented by "Yes" (flare-up) or "No" (no flare-up). It will be recorded on chart that will given to the patients after the initial treatment. | Presence of flare-ups will be recorded each day after the intracanal medication placement visit till the next visit (after seven days). |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
| D006878 |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |