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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04319575
Enrollment
40
Registered
2020-03-24
Start date
2018-12-03
Completion date
2020-08-04
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Abscess

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.

Interventions

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.

Sponsors

Dr. D. Y. Patil Dental College & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
healing of periapical lesionchange in PAI index from baseline to 3 months, baseline to 6 months and baseline to 12 monthsthe 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

MeasureTime frameDescription
patient pain perception3months, 6months and 12 monthspain 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

Countries

India

Contacts

Primary ContactSoumya S Shetty, MDS
drsoumyasshetty@gmail.com8888200888
Backup ContactAnita B Tandale, MDS
anita.tandale@gmail.com9850537432

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026