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Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth

NCT06506526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-07-17

No results posted yet for this study

Summary

45 teeth will be sub-divided at random with a computerized method, according to the type irrigant and duration of its application into 3 groups (15 teeth in each group):

Group1(control group):

The teeth will be irrigated by 2 ml 1% NaOCl after each file.

Group2:

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.

Group 3:

The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for 3 minutes.

Evaluation

Clinical evaluation will be done for all groups at one, three, six and 12 months. The following parameters will be evaluated: Pain (spontaneous pain and pain with percussion) Degree of mobility Resolution of signs of infection (fistula) at the mucobuccal fold.

Radiographical evaluation will be performed to each patient immediately after the final restoration and three, six and 12 months postoperatively.

The decrease of radiolucency and the presence of internal or external root resorption will be evaluated.

Bacteriology :

The microbiological evaluation will be done at the Biotechnology Research Institute - Suez Canal University.

PCR will be used for detection of Enterococcus faecalis. Microbiological investigation will be used for counting the number of Enterococcus faecalis.

Conditions

  • Pulpal Necrosis

Interventions

PROCEDURE

Sodium hypochlorite irrigating solution

2 ml 1% NaOCl after each file

PROCEDURE

one minute NaOCL+Chitosan

2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.

PROCEDURE

Three minute NaOCL+Chitosan

2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute.

Sponsors & Collaborators

  • Suez Canal University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-11-14
Completion
2023-12-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506526 on ClinicalTrials.gov