Effect of Probiotics, Double Antibiotic Paste, and Calcium Hydroxide on Postoperative Pain in Irreversible Pulpitis: A Randomized Trial

NCT07270159 | Completed DMC

• 1 other identifier: 181
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether probiotics, double antibiotic paste (DAP), or calcium hydroxide paste help reduce postoperative pain after root canal treatment in adults with symptomatic irreversible pulpitis. It will also learn about the safety of these medicaments. The main questions it aims to answer are: Do probiotics, DAP, or calcium hydroxide lower the amount of pain patients experience after the first visit of root canal treatment? What medical problems or side effects do participants experience when any of these medicaments are used? Researchers will compare probiotics, DAP, and calcium hydroxide to see which one works best to control postoperative pain. Participants will: Receive one of the three intracanal medicaments (probiotics, DAP, or Ca(OH)₂) placed inside their root canal Visit the clinic for follow-ups according to the treatment plan Report their pain levels using a Visual Analog Scale (VAS) at several time points (before treatment, 12 hrs, 24 hrs, 48 hrs, 3 days, and 7 days) Inform the research team about any discomfort, symptoms, or side effects during the week after treatment

Conditions

Root Canal Treatment; Irreversible Pulpitis With Apical Periodontitis; Pulpitis - Irreversible; Post Operative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Change in postoperative pain levels following root canal treatment, measured using the Visual Analog Scale (VAS). VAS is a 10-point scale where 0 = no pain and 10 = worst possible pain. Participants will report their pain at multiple time points to evaluate how each intracanal medicament (Calcium Hydroxide, Double Antibiotic Paste, Probiotic Paste) influences pain reduction over time.

  Preoperative 12 hours postoperative 24 hours postoperative 48 hours postoperative 3 days postoperative 7 days postoperative

Study Arms (2)

Calcium Hydroxide

ACTIVE COMPARATOR

Intrcanal medicament used in RCT

Drug: Probiotic

Double Antibiotic Paste (DAP)

ACTIVE COMPARATOR

Intracanal medicament used in RCT

Drug: Probiotic

Interventions

Probiotic DRUG

New intracanal medicament used in RCT

Calcium Hydroxide; Double Antibiotic Paste (DAP)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients falling in ASA 1 category
• Suffering from symptomatic irreversible pulpitis with range from moderate to severe. In addition to this patient should also have experienced lingering of pain. VAS score will be used to record pain. (Confirmed by clinical and radiographic signs) with or without apical periodontitis.
• Multirooted teeth (Mandibular 1st and 2nd molars)
• Age 18-45 year
• Teeth with a Periapical Index (PAI) score of 1 -3, indicating a healthy periapical status or minimal changes in bone structure not necessarily associated with apical periodontitis, were included in this study.

You may not qualify if:

• Pregnant or lactating mothers
• Subjects taking chronic pain medications within last 24 hrs.
• Cracks, complex anatomy, pulp calcification

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow International Dental College

Karachi, Sindh, 12345, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 8, 2025
• Study Start: June 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 10, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-05

Locations

PA (1)