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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-02-15

Brief Summary

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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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Detailed Description

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Conditions

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Calcium Hydroxide + Saline

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

Group Type PLACEBO_COMPARATOR

Calcium Hydroxide + Normal Saline

Intervention Type DRUG

Calcium hydroxide powder mixed with sterile normal saline and placed inside the root canal as intracanal medicament.

Calcium Hydroxide + 0.2% Chlorhexidine

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.

Group Type EXPERIMENTAL

Calcium Hydroxide + 0.2% Chlorhexidine Digluconate

Intervention Type DRUG

Calcium hydroxide powder combined with 0.2% chlorhexidine solution and placed inside the root canal as intracanal medicament.

Interventions

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Calcium Hydroxide + Normal Saline

Calcium hydroxide powder mixed with sterile normal saline and placed inside the root canal as intracanal medicament.

Intervention Type DRUG

Calcium Hydroxide + 0.2% Chlorhexidine Digluconate

Calcium hydroxide powder combined with 0.2% chlorhexidine solution and placed inside the root canal as intracanal medicament.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No