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

NCT06821763 | Not Yet Recruiting Phase 2

• 1 other identifier: DK/248/24
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Apical Periodontitis; Irreversible Pulpitis with Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• post operative pain

  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

Study Arms (2)

Group A( calcium hydroxide)

ACTIVE COMPARATOR

patients receiving calcium hydroxide as intra canal medicament

Drug: Calcium Hydroxide Intracanal medication

Group B( Triple Antibiotic Paste)

ACTIVE COMPARATOR

Patients receiving triple antibiotic paste as intra canal medicament

Drug: triple antibiotic paste (TAP)

Interventions

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

Group A( calcium hydroxide)

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.

Group B( Triple Antibiotic Paste)

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Komal Ashraf Khan: lead

Study Sites (1)

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

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Central Study Contacts

Komal Ashraf Khan

CONTACT

+92 3129433556; komalashraf152@gmail.com

Dr. Lubna Pasha

CONTACT

+92 333 9499959

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Post Graduate Trainee

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 12, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)