Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03588351
Collaborator
(none)
45
1
3
7.9
5.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: chitosan nanoparticles gel
  • Drug: chitosan gel
  • Drug: chlorhexidine gluconate
N/A

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.

  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Chitosan,Chitosan Nanoparticles,and Chlorhexidine Gluconate, as Intra Canal Medicaments in Primary Teeth: An In-vivo Study
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Aug 15, 2018
Anticipated Study Completion Date :
Aug 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: chlorhexidine gluconate

GROUP I: - 15 teeth will be treated with specially prepared gel containing chlorhexidine gluconate as intracanal medicament .

Drug: chlorhexidine gluconate
intracanal medicament
Other Names:
  • CHX
  • Experimental: chitosan nanoparticles gel

    GROUP II: - 15 teeth will be treated with specially prepared gel containing chitosan nanoparticles that ready to use as intracanal medicament.

    Drug: chitosan nanoparticles gel
    intracanal medicament
    Other Names:
  • CSNPs
  • Experimental: chitosan gel

    Group III: 15teeth will be treated with specially prepared gell containing chitosan that ready to use as intra medicament .

    Drug: chitosan gel
    intracanal medicament
    Other Names:
  • CS
  • Outcome Measures

    Primary Outcome Measures

    1. 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. [3 month]

      antibacterial effect of Chlorhexidine Gluconate, Chitosan,Chitosan Nanoparticl on necrotic primary tooth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain shames university faculty of dentistry Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Marwa A Abozed, BDSC, Faculty of Dentistry Ain shams University, Cairo, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Ahmed Abozed, Marwa Ahmed Abozed, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03588351
    Other Study ID Numbers:
    • PED-3-17
    First Posted:
    Jul 17, 2018
    Last Update Posted:
    Jul 17, 2018
    Last Verified:
    Jul 1, 2018
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 17, 2018