MedPath

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

Phase 2
Conditions
Periapical Abscess
Interventions
Drug: root canal treatment and intracanal medicament
Registration Number
NCT04319575
Lead Sponsor
Dr. D. Y. Patil Dental College & Hospital
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.

Detailed 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 & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chitosan calcium hyroxide pasteroot canal treatment and intracanal medicamentafter the access preparation and cleaning and shaping, chitosan calcium hydroxide paste will be placed in the canal and kept for 4 weeks.
triple antibiotic pasteroot canal treatment and intracanal medicamentafter the access preparation and cleaning and shaping, ciprofloxacin metronidazole minocycline paste will be :placed in the canal and kept for 4 weeks.
Primary Outcome Measures
NameTimeMethod
healing of periapical lesionchange in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 months

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

Secondary Outcome Measures
NameTimeMethod
patient pain perception3months, 6months and 12 months

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

Trial Locations

Locations (1)

Dr DY Patil Dental College And Hospital (DPU)

🇮🇳

Pune, Maharashtra, India

© Copyright 2025. All Rights Reserved by MedPath