Comparison of Frequency of Calcium Hydroxide Mixed With 0.2% Chlorhexidine Versus Saline as Intracanal Medicament in Periapical Periodontitis-A Randomized Controlled Trial

Aqsa Afzal

Status: Active, not recruiting

Conditions: Periapical Periodontitis

Treatments: Drug: Calcium Hydroxide + Normal Saline; Drug: Calcium Hydroxide + 0.2% Chlorhexidine Digluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT07252258

118-ERB/023

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patients age 18 or above 18 year old (to have complete apex formation)

  • Anterior teeth with apical periodontitis (simple root canal morphology)
  • Patients whose medical history does not include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).

Exclusion criteria

• Patient allergic to chlorhexidine digluconate and Calcium hydroxide assessed by history.
• Tooth having necrotic pulp on radiographic examination and electric pulp tester.
• Multiple rooted teeth.
• Previously root canal treated tooth because of procedural errors and periapical infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Calcium Hydroxide + Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Calcium Hydroxide + Normal Saline

Calcium Hydroxide + 0.2% Chlorhexidine

Experimental group

Description:

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.

Treatment:

Drug: Calcium Hydroxide + 0.2% Chlorhexidine Digluconate