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

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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Key information

Conditions

Periapical Periodontitis Jaw Diseases Mouth Diseases Periapical Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saidu College of Dentistry Swat

Swāt, Khyber Pakhtunkhwa, 19200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calcium Hydroxide + Normal Saline

Drug

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

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.

Primary outcomes

primary outcome measure

Time frame: 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours).

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.

Sponsors and collaborators

Lead sponsor

Aqsa Afzal

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 26, 2025
Registry last updated: Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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