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

NCT04319575 | Unknown Phase 2 DMC

• 1 other identifier: DYPV/EC/55/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periapical Abscess

Outcome Measures

Primary Outcomes (1)

• 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 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

  change in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months

Secondary Outcomes (1)

• patient pain perception

  3months, 6months and 12 months

Study Arms (2)

Chitosan calcium hyroxide paste

EXPERIMENTAL

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

triple antibiotic paste

ACTIVE COMPARATOR

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

Interventions

root canal treatment and intracanal medicament 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.

Also known as: intra-oral periapical radiaograph,"kodak"

Chitosan calcium hyroxide paste; triple antibiotic paste

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

Study Sites (1)

Dr DY Patil Dental College And Hospital (DPU)

Pune, Maharashtra, 411 018, India

RECRUITING

MeSH Terms

Conditions

Periapical Abscess

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Piyush D Oswal, MDS

  Dr. D Y Patil Dental College, Pimpri, Pune

  STUDY DIRECTOR

Central Study Contacts

Soumya S Shetty, MDS

CONTACT

8888200888; drsoumyasshetty@gmail.com

Anita B Tandale, MDS

CONTACT

9850537432; anita.tandale@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: December 3, 2018
• Primary Completion: April 23, 2020
• Study Completion: August 4, 2020
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

IN (1)