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

Last updated: February 10, 2025
Sponsor: Komal Ashraf Khan
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Pain

Acute And Chronic Dental Pain

Periodontitis

Treatment

Calcium Hydroxide Intracanal medication

triple antibiotic paste (TAP)

Clinical Study ID

NCT06821763
DK/248/24
  • Ages 12-45
  • All Genders

Study Summary

  • 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of both genders having age 12-45 years

  • Newly diagnosed cases fulfilling the criteria of INTERNATIONAL ASSOCIATES FOR THESTUDY 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

Exclusion Criteria:

  • Patients who have allergies, sensitivity or unable to take medications, periodontaldisease, acute endodontic or periodontal abscess, requiring prophylacticantibiotics, systemic diseases like hypertension, diabetes, liver dysfunction renalfailure 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, chronicperiodontitis, internal/external root resorption.

  • Patients with serious medical illness, systemic disorders, immunocompromiseddiseases such as AIDS or HBV.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Calcium Hydroxide Intracanal medication
Phase: 2/3
Study Start date:
May 01, 2025
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • Margalla Institute Of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz housing scheme Rawalpindi

    Rawalpindi, Punjab 46000
    Pakistan

    Site Not Available

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