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

Periapical Abscess Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319575
• Other study ID #: DYPV/EC/55/16
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 3, 2018
• Est. completion date: August 4, 2020

Study information

• Verified date: March 2020
• Source: Dr. D. Y. Patil Dental College & Hospital
• Contact: Soumya S Shetty, MDS
• Phone: 8888200888
• Email: drsoumyasshetty[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 4, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Abscess

Intervention

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.

Locations

Country	Name	City	State
India	Dr DY Patil Dental College And Hospital (DPU)	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Dr. D. Y. Patil Dental College & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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