Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
Primary Purpose
Periapical Abscess
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
root canal treatment and intracanal medicament
Sponsored by
About this trial
This is an interventional treatment trial for Periapical Abscess
Eligibility 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.
Sites / Locations
- Dr DY Patil Dental College And Hospital (DPU)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chitosan calcium hyroxide paste
triple antibiotic paste
Arm Description
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
Outcomes
Primary Outcome Measures
healing of periapical lesion
the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as
Normal periapical structures
Small changes in bone structure
Changes in bone structure with some mineral loss
Periodontitis with well-defined radiolucent area
Severe periodontitis with exacerbating features
Secondary Outcome Measures
patient pain perception
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
Full Information
NCT ID
NCT04319575
First Posted
March 18, 2020
Last Updated
March 21, 2020
Sponsor
Dr. D. Y. Patil Dental College & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04319575
Brief Title
Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
April 23, 2020 (Anticipated)
Study Completion Date
August 4, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chitosan calcium hyroxide paste
Arm Type
Experimental
Arm Description
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
Arm Title
triple antibiotic paste
Arm Type
Active Comparator
Arm Description
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
root canal treatment and intracanal medicament
Other Intervention Name(s)
intra-oral periapical radiaograph,"kodak"
Intervention Description
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.
Primary Outcome Measure Information:
Title
healing of periapical lesion
Description
the periapical status will be assessed by using the periapical index [PAI] using radiographs and scoring was done according to following scoring index as
Normal periapical structures
Small changes in bone structure
Changes in bone structure with some mineral loss
Periodontitis with well-defined radiolucent area
Severe periodontitis with exacerbating features
Time Frame
change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months
Secondary Outcome Measure Information:
Title
patient pain perception
Description
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
Time Frame
3months, 6months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soumya S Shetty, MDS
Phone
8888200888
Email
drsoumyasshetty@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anita B Tandale, MDS
Phone
9850537432
Email
anita.tandale@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piyush D Oswal, MDS
Organizational Affiliation
Dr. D Y Patil Dental College, Pimpri, Pune
Official's Role
Study Director
Facility Information:
Facility Name
Dr DY Patil Dental College And Hospital (DPU)
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soumya S Shetty, MDS
Phone
8888200888
Email
drsoumyasshetty@gmail.com
First Name & Middle Initial & Last Name & Degree
anita B Tandale, MDS
Phone
9850537432
Email
anita.tandale@gmail.com
First Name & Middle Initial & Last Name & Degree
soumya S shetty, MDS
First Name & Middle Initial & Last Name & Degree
anita B tandale, MDS
First Name & Middle Initial & Last Name & Degree
piyush D oswal, MDS
12. IPD Sharing Statement
Learn more about this trial
Comparison of Triple Antibiotic Paste With Combination of Chitosan and Calcium Hydroxide as a Root Canal Disinfectant
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