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NCT Number: NCT06821763

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

* 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).

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Key information

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Rawalpindi, Punjab Province, 46000, Pakistan

Location contact

Prof Dr Amjad Mehmood Dean MIHS

CONTACT

[email protected]

051-5509640

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Calcium Hydroxide Intracanal medication

Drug

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

triple antibiotic paste (TAP)

Drug

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Lubna Pasha

CONTACT

+92 333 9499959

Komal Ashraf Khan

CONTACT

[email protected]

+92 3129433556

Sponsors and collaborators

Lead sponsor

Komal Ashraf Khan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 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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