ClinicalTrials.Veeva

Menu

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

D

Dr. D. Y. Patil Dental College & Hospital

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Periapical Abscess

Treatments

Drug: root canal treatment and intracanal medicament

Study type

Interventional

Funder types

Other

Identifiers

NCT04319575
DYPV/EC/55/16

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Chitosan calcium hyroxide paste
Experimental group
Description:
after the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
Treatment:
Drug: root canal treatment and intracanal medicament
triple antibiotic paste
Active Comparator group
Description:
after the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
Treatment:
Drug: root canal treatment and intracanal medicament

Trial contacts and locations

1

Loading...

Central trial contact

Soumya S Shetty, MDS; Anita B Tandale, MDS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems