Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant

March 21, 2020 updated by: Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital

Clinical and Radiographic Comparative Evaluation of Healing of Periapical Lesion Using Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide When Used as a Root Canal Disinfectant- An In Vivo Study

Investigators observed the clinical and radiographic healing of periapical lesion using Chitosan mixed with calcium hydroxide and compared it with triple antibiotic paste when used as intracanal medicament in 3months, 6 months and 12 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim: To evaluate and compare the healing of periapical lesions using chitosan mixed with calcium hydroxide or Triple Antibiotic Paste at 3,6 and 12 months.

Methodology:

20 adult patients having periapical lesions in single rooted teeth were selected in this study after being assessed using the PAI index. Patients were randomly assigned to: Group - I (n=10) Chitosan with Ca (OH)2 and Group -II (n=10) Triple Antibiotic paste (TAP)

After access opening and cleaning and shaping were done in the first visit, the pertinent intracanal medicaments were placed depending on the patient group. After 4 weeks, on the second visit, the medicament was removed andobturation was done in the asymptomatic teeth. Both clinical and radiographic endodontic evaluation was done at 0, 3, 6 and 12months using the same parameters.

Radiographic evaluation was done using the PAI Index and was compared at 0, 3, 6, and 12 months after treatment, Z Test.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411 018
        • Recruiting
        • Dr DY Patil Dental College And Hospital (DPU)
        • Contact:
        • Contact:
        • Principal Investigator:
          • soumya S shetty, MDS
        • Sub-Investigator:
          • anita B tandale, MDS
        • Sub-Investigator:
          • piyush D oswal, MDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 40 years Periapical lesion (not more than 5mm) radiographically.on single rooted teeth
  • Roots with closed apex.
  • Systemically healthy patients.

Exclusion Criteria:All patients who respond positive to allergic patch test [triple antibiotic paste] and drugs.

  • Teeth with previous endodontic therapy performed.
  • Patients with a history of any systemic diseases.
  • Pregnant and lactating women.
  • Tooth associated with vertical root fracture and coronal perforation.
  • Tooth affected with calcific degeneration.
  • Presence of external or internal root resorption.
  • Blunderbuss apex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chitosan calcium hyroxide paste
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
Drug: root canal treatment and intracanal medicament
after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks.
Other Names:
  • intra-oral periapical radiaograph,"kodak"
Active Comparator: triple antibiotic paste
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
Drug: root canal treatment and intracanal medicament
after the access preparation and cleaning and shaping was done in 1st appointment using k files,"Mani" and protapers,"Dentsply" then in, chitosan calcium hydroxide paste," or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks.
Other Names:
  • intra-oral periapical radiaograph,"kodak"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing of periapical lesion
Time Frame: change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months

the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as

  1. Normal periapical structures
  2. Small changes in bone structure
  3. Changes in bone structure with some mineral loss
  4. Periodontitis with well-defined radiolucent area
  5. Severe periodontitis with exacerbating features
change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient pain perception
Time Frame: 3months, 6months and 12 months
pain will be assessed using visual analogue (VAS )scale along with any swelling following scale of -10 with 0 score depicts no pain and score 10 depicts severe pain
3months, 6months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. D. Y. Patil Dental College & Hospital

Investigators

  • Study Director: Piyush D Oswal, MDS, Dr. D Y Patil Dental College, Pimpri, Pune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2018

Primary Completion (Anticipated)

April 23, 2020

Study Completion (Anticipated)

August 4, 2020

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYPV/EC/55/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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