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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12-45
SponsorKomal Ashraf Khan

About this trial

* 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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Group A( calcium hydroxide)Active comparator 1 intervention
Group B: Group B( Triple Antibiotic Paste)Active comparator 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Komal Ashraf Khan

Lead sponsor

Margalla Institute of Health Sciences

Sponsor institution

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