Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth
Primary Purpose
Necrotic Pulp
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
chitosan nanoparticles gel
chitosan gel
chlorhexidine gluconate
Sponsored by
About this trial
This is an interventional treatment trial for Necrotic Pulp
Eligibility Criteria
Inclusion Criteria:
- Apparently healthy children.
- Age 4-7 years
- Children should have at least one non vital and restorable mandibular molar .
- Cooperative children.
- Children that did not take any antibiotic for at least one month before sample collection
Exclusion Criteria:
- Medically compromised children.
- Children under antibiotic therapy.
- Non restorable molars.
- Root resorption more then half of the root length.
Sites / Locations
- Ain shames university faculty of dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
chlorhexidine gluconate
chitosan nanoparticles gel
chitosan gel
Arm Description
GROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament .
GROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament.
Group III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament .
Outcomes
Primary Outcome Measures
assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars.
antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03588351
Brief Title
Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth
Official Title
Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth: An In-vivo Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Anticipated)
Study Completion Date
August 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of the present study is to assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticles ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars
Detailed Description
Primary teeth with necrotic pulp are a common problem in pediatric dentistry especially in very young children before first permanent molar eruption. Early loss of primary teeth can cause a number of problems, including space loss, esthetic, phonetic or functional problems. However, some of the infected primary teeth can remain functional until the exfoliation via endodontic treatment. Pulpectomy is indicated in primary teeth with necrotic pulp in which the radicular tissue exhibits clinical signs of chronic inflammation.
The primary objective of pulp therapy is to maintain the integrity and health of the teeth and their supporting tissues. One of the most important aims of pulpectomy treatment is to eradicate or substantially reduce the microbial load in the root canal system. Currently, insignificant data is available regarding the identification of microbiota in deciduous teeth with pulp necrosis and periapical pathosis. However, documentation exists in relation to the polymicrobial nature of microbes predominated by anaerobes in the root canals of deciduous teeth with necrotic pulp and periapical lesions similar to permanent teeth.
Various microorganisms isolated from infected root canals include Streptococci, Staphylo-coccus, Diptheroids, Peptostreptococcus, Lactoba-cilli, Propionibacterium, Actinomyces, Bacteroides, Fusobacterium etc.
The commonly isolated facultative anaerobes microorganisms from primary root canals, Enterococcus faecalis was isolated in 30% of cases, Escherichia coli in 28.4%, Staphylococcus aureus in 25%, α-hemolytic Streptococci in 15% and Proteus mirabilis in 1.6% of cases.
E. faecalis is a persistent organism that plays a major role in the etiology of persistent periradicular lesions after root canal treatment. It is commonly found in high percentage of root canal failures and is able to survive in the root canal as a single organism or as a major component of the flora.
Therefore, intracanal medication was advocated to further reduce bacteria in the root canal system and reduce the failure of root canal treatment. Thus, chemomechanical debridement using intracanal medicament and irrigants is essential to eliminate these microorganisms, and their by-products that remained in the pulpal space which was inaccessible to systemic antibiotics and root canal instrumentations.
Chlorhexidine (CHX) usually used as a root canal irrigant especially in primary molars owing to its biocompatibility, substantivity and wide antimicrobial activity.
Recently there is an increase interest in using natural product in medical fields. Chitosan is a natural and non-toxic polysaccharide with many biological applications, particularly as an antimicrobial agent. Chitosan nanoparticle is a bioactive and environment friendly material with unique physicochemical properties .
To date, none of the studies has consistently investigated the effects of Chitosan as new alternative when used as root canal medicament in primary teeth. Therefore the present study aimed to compare in vivo susceptibility of root canal bacteria to chitosan, chitosan nanoparticals, and chlorhexidine gluconate as intra canal medicaments in necrotic primary molars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotic Pulp
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chlorhexidine gluconate
Arm Type
Active Comparator
Arm Description
GROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament .
Arm Title
chitosan nanoparticles gel
Arm Type
Experimental
Arm Description
GROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament.
Arm Title
chitosan gel
Arm Type
Experimental
Arm Description
Group III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament .
Intervention Type
Drug
Intervention Name(s)
chitosan nanoparticles gel
Other Intervention Name(s)
CSNPs
Intervention Description
intracanal medicament
Intervention Type
Drug
Intervention Name(s)
chitosan gel
Other Intervention Name(s)
CS
Intervention Description
intracanal medicament
Intervention Type
Drug
Intervention Name(s)
chlorhexidine gluconate
Other Intervention Name(s)
CHX
Intervention Description
intracanal medicament
Primary Outcome Measure Information:
Title
assess the in vivo susceptibility of root canal bacteria to Chitosan,Chitosan nanoparticals ,and Chlorhexidine gluconate when used as intra canal medicaments in necrotic primary molars.
Description
antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Apparently healthy children.
Age 4-7 years
Children should have at least one non vital and restorable mandibular molar .
Cooperative children.
Children that did not take any antibiotic for at least one month before sample collection
Exclusion Criteria:
Medically compromised children.
Children under antibiotic therapy.
Non restorable molars.
Root resorption more then half of the root length.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa A Abozed, BDSC
Organizational Affiliation
Faculty of Dentistry Ain shams University, Cairo, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shames university faculty of dentistry
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth
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