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
NCT ID: NCT06821763
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
180 participants
INTERVENTIONAL
2025-05-01
2025-11-01
Brief Summary
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* 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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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A( calcium hydroxide)
patients receiving calcium hydroxide as intra canal medicament
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
Group B( Triple Antibiotic Paste)
Patients receiving triple antibiotic paste as intra canal medicament
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
45 Years
ALL
No
Sponsors
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Komal Ashraf Khan
OTHER
Responsible Party
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Komal Ashraf Khan
Post Graduate Trainee
Locations
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Margalla Institute Of Health Sciences Quaid e Azam Avenue, Gulraiz phase 3, Gulraiz housing scheme Rawalpindi
Rawalpindi, Punjab Province, Pakistan
Countries
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Central Contacts
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Dr. Lubna Pasha
Role: CONTACT
Facility Contacts
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Other Identifiers
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DK/248/24
Identifier Type: -
Identifier Source: org_study_id
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