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

NCT07252258 | Active Not Recruiting DMC

• 1 other identifier: 118-ERB/023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periapical Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

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

Drug: Calcium Hydroxide + Normal Saline

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.

Drug: Calcium Hydroxide + 0.2% Chlorhexidine Digluconate

Interventions

Calcium Hydroxide + Normal Saline DRUG

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

Calcium Hydroxide + Saline

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.

Calcium Hydroxide + 0.2% Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aqsa Afzal: lead

Study Sites (1)

Saidu College of Dentistry Swat

Swāt, Khyber Pakhtunkhwa, 19200, Pakistan

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Calcium Hydroxide; Saline Solution; chlorhexidine gluconate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: FAyoub

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: July 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 15, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

PA (1)