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This randomized controlled trial aims to compare the effectiveness of calcium hydroxide mixed with 0.2% chlorhexidine digluconate versus calcium hydroxide mixed with saline as intracanal medicaments in reducing postoperative pain in patients with apical periodontitis. A total of 80 adult patients with anterior teeth diagnosed with apical periodontitis will be randomly assigned to two equal groups. After standard chemomechanical root canal preparation, Group A will receive calcium hydroxide with saline, while Group B will receive calcium hydroxide with 0.2% chlorhexidine. Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS) at 12, 24, and 48 hours. The primary outcome is the frequency and severity of pain at 24 hours. Data will be analyzed using chi-square or Fisher's exact test, with a significance level of p < 0.05. The study aims to determine whether the addition of chlorhexidine improves the analgesic and antimicrobial effectiveness of calcium hydroxide during root canal treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Hydroxide + Saline | Placebo Comparator | Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with normal saline after standard chemomechanical root canal preparation. Temporary restoration will be placed, and postoperative pain will be assessed at designated intervals |
|
| Calcium Hydroxide + 0.2% Chlorhexidine | Experimental | Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with 0.2% chlorhexidine digluconate following standard root canal procedures. Temporary restoration will be placed, and postoperative pain will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Hydroxide + Normal Saline | Drug | Calcium hydroxide powder mixed with sterile normal saline and placed inside the root canal as intracanal medicament. |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary outcome measure | Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS), where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. | 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours). |
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Inclusion Criteria:
• Patients age 18 or above 18 year old (to have complete apex formation)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saidu College of Dentistry Swat | Swāt | Khyber Pakhtunkhwa | 19200 | Pakistan |
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| Calcium Hydroxide + 0.2% Chlorhexidine Digluconate | Drug | Calcium hydroxide powder combined with 0.2% chlorhexidine solution and placed inside the root canal as intracanal medicament. |
|
| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
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| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| D000077330 | Saline Solution |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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