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

NCT ID: NCT04319575

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2020-08-04

Brief Summary

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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

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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.

Conditions

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Periapical Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

root canal treatment and intracanal medicament

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

root canal treatment and intracanal medicament

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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intra-oral periapical radiaograph,"kodak"

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soumya Shetty

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piyush D Oswal, MDS

Role: STUDY_DIRECTOR

Dr. D Y Patil Dental College, Pimpri, Pune

Locations

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Dr DY Patil Dental College And Hospital (DPU)

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Soumya S Shetty, MDS

Role: CONTACT

8888200888

Anita B Tandale, MDS

Role: CONTACT

9850537432

Facility Contacts

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Soumya S Shetty, MDS

Role: primary

8888200888

anita B Tandale, MDS

Role: backup

9850537432

Other Identifiers

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DYPV/EC/55/16

Identifier Type: -

Identifier Source: org_study_id

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