To Measure Post Operative Pain Severity by Using Two Different Intra Canal Medicaments Calcium Hydroxide and Triple Antibiotic Paste in Teeth with Single Roots and Periapical Disease Called Apical Periodontitis

February 10, 2025 updated by: Komal Ashraf Khan

Effect of Calcium Hydroxide on Post Operative Pain Severity in Single Rooted Teeth with Symptomatic Apical Periodontitis

  • The aim of this study is to compare post operative pain effectiveness between two most commonly available intra canal medicaments that are Triple Antibiotic Paste and Calcium Hydroxide during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
  • Patients visiting OPD will be selected after fulfilment of inclusion criteria and randomly divided into two groups i.e group A patients receiving calcium hydroxide and group B with patients receiving Triple Antibiotic Paste as intra canal medicaments
  • Patient will be called at 48hrs 72hrs and 96hrs postoperatively.
  • Effectiveness of intra canal medicaments will be measured as no mild moderate severe on visual analogue scale(VAS).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • This randomized control study is done to compare post operative pain effectiveness of two medicaments that are triple antibiotic paste (TAP)(ciprofloxacin, metronidazole and minocycline in ratio 1:1:1) and calcium hydroxide(CH) during root canal treatment of single rooted teeth with symptomatic apical periodontitis.
  • Calcium hydroxide being strong base exerts antimicrobial efficiency in reducing and eliminating microorganisms in entire root canal system
  • TAP is efficient against calcium hydroxide resistant bacteria called as enterococcus faecalis and provides antimicrobial efficiency to inner depths of root canal up to 400 microns.
  • This study will add further to literature regarding better intracanal medicament among two most widely used.
  • Sample size includes total 180 participants having two groups each containing 90.
  • Inclusion criteria have patients with age group 12-45, single rooted teeth, having symptomatic apical periodontitis, patients fulfilling international associates definition of pain
  • Exclusion criteria includes patients having allergies, unable to take medications, medical conditions like diabetes etc, pregnant patients, teeth with tooth abnormalities like dilacerations open apices etc
  • Patients will be selected from OPD after fulfilment of inclusion criteria randomly divided into two groups using lottery method
  • Group A receiving calcium hydroxide group B receiving triple antibiotic paste
  • Patients will be called post operatively after 48hrs 72hrs and 96hrs
  • Post operative pain effectiveness will be measured as no mild moderate and severe on visual analogue scale (VAS)
  • The data will be analyzed in statistical software SPSS v 25. Chi square test will be applied to compare effectiveness in both groups keeping p value less than 0.05 as significant.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr. Lubna Pasha
  • Phone Number: +92 333 9499959

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Margalla Institute Of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz housing scheme Rawalpindi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of both genders having age 12-45 years
  • Newly diagnosed cases fulfilling the criteria of INTERNATIONAL ASSOCIATES FOR THE STUDY OF PAIN definition of pain.
  • A Single rooted teeth (Anterior or Posterior)
  • Teeth with symptomatic apical periodontitis
  • Teeth with necrotic pulp that gave a negative response to vitality testing.

Exclusion Criteria:

  • Patients who have allergies, sensitivity or unable to take medications, periodontal disease, acute endodontic or periodontal abscess, requiring prophylactic antibiotics, systemic diseases like hypertension, diabetes, liver dysfunction renal failure and mental disabilities were excluded.
  • Pregnant ladies or patients on nursing were also excluded from the sample.
  • Teeth with anatomical difficulties such as open apices.
  • Teeth with severe dilacerations, calcified canals, occlusal interferences, chronic periodontitis, internal/external root resorption.
  • Patients with serious medical illness, systemic disorders, immunocompromised diseases such as AIDS or HBV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A( calcium hydroxide)
patients receiving calcium hydroxide as intra canal medicament
Drug: Calcium Hydroxide Intracanal medication
non setting calcium hydroxide(CH) mixed with normal saline and placed as intra canal medicament during first visit of root canal treatment. effectiveness measured after 48hrs, 72hrs and 96hrs
Active Comparator: Group B( Triple Antibiotic Paste)
Patients receiving triple antibiotic paste as intra canal medicament
Drug: triple antibiotic paste (TAP)
mix metronidazole, ciprofloxacin and minocycline in ratio 1:1:1 with normal saline and placed as intra canal medicament during first visit of root canal treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain
Time Frame: 6 months
post operative pain measured through visual analogue scale( VAS) from readings no pain 0, mild taken as 0-2, moderate as 2-5, severe taken as 5-10
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Komal Ashraf Khan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK/248/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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