Clinical, Radiographical and Microbiological Evaluation of Chitosan as Irrigating Solution for Pulpectomy in Non-Vital Primary Teeth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Bacteriology
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Months to 7 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Apparently healthy Children aged from three to seven years.
- •No previous history of antibiotics for at least two weeks.
- •Non- Vital primary teeth that can be fully isolated.
- •Presence of clinical signs or symptoms suggesting a non-vital tooth, such as intra-oral fistula.
- •Infection diagnosed by presence of periapical radiolucency in a periapical radiograph.
- •Root resorption not more than one third of the root.
- •Patient and parent cooperation.
Exclusion Criteria
- •Non-restorable tooth
- •Serious reduction in bone support and/or extreme tooth mobility.
- •Radiographic indication of extensive internal or external root resorption.
Arms & Interventions
Control group
The teeth will be irrigated by 2 ml 1% NaOCl after each file.
Intervention: Sodium hypochlorite irrigating solution (Procedure)
One-minute NaOCL+Chitosan
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for one minute.
Intervention: one minute NaOCL+Chitosan (Procedure)
Three-minute NaOCL+Chisosan
The teeth will be irrigated by 2 ml 1% NaOCl after each file then with 5 ml of 0.2% chitosan for three minute.
Intervention: Three minute NaOCL+Chitosan (Procedure)
Outcomes
Primary Outcomes
Bacteriology
Time Frame: During procedure
PCR will be used for detection of Enterococcus faecalis. \- Microbiological investigation will be used for counting the number of Enterococcus faecalis
Spontanous Pain
Time Frame: after one month, 3 months, six months and 12 months
Visual analog scale "A scale from 1 to 10 where 1 is mild pain and 10 Worst pain"
Radiographic examination " internal or external root resorption"
Time Frame: immediately after restoration, 3 months, six months and 12 months
Presence (1) or absence (0)
Radiographical evaluation
Time Frame: immediately after restoration, 3 months, six months and 12 months
The change of radiolucency
Secondary Outcomes
No secondary outcomes reported