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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319575
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periapical Abscess Drug: root canal treatment and intracanal medicament Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : April 23, 2020
Estimated Study Completion Date : August 4, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: intra-oral periapical radiaograph,"kodak"




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319575


Contacts
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Contact: Soumya S Shetty, MDS 8888200888 drsoumyasshetty@gmail.com
Contact: Anita B Tandale, MDS 9850537432 anita.tandale@gmail.com

Locations
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India
Dr DY Patil Dental College And Hospital (DPU) Recruiting
Pune, Maharashtra, India, 411 018
Contact: Soumya S Shetty, MDS    8888200888    drsoumyasshetty@gmail.com   
Contact: anita B Tandale, MDS    9850537432    anita.tandale@gmail.com   
Principal Investigator: soumya S shetty, MDS         
Sub-Investigator: anita B tandale, MDS         
Sub-Investigator: piyush D oswal, MDS         
Sponsors and Collaborators
Dr. D. Y. Patil Dental College & Hospital
Investigators
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Study Director: Piyush D Oswal, MDS Dr. D Y Patil Dental College, Pimpri, Pune
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Responsible Party: Soumya Shetty, professor, Dr. D. Y. Patil Dental College & Hospital
ClinicalTrials.gov Identifier: NCT04319575    
Other Study ID Numbers: DYPV/EC/55/16
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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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
Additional relevant MeSH terms:
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Periapical Abscess
Abscess
Suppuration
Infection
Periapical Periodontitis
Periapical Diseases
Jaw Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periodontitis