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

Study Overview
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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.

Official Title
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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

Conditions
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Periapical Abscess

Intervention / Treatment
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* Drug: root canal treatment and intracanal medicament


Participation Criteria
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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: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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chitosan calcium hyroxide paste<br>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<br>* 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.<br>* Other names: intra-oral periapical radiaograph,kodak;|
| Active Comparator: triple antibiotic paste<br>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<br>* 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.<br>* Other names: intra-oral periapical radiaograph,kodak;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 |