Evaluation of the Antibacterial Effect of Laser Diode and Zinc Oxide Nano Particles in Cavity Disinfection
Evaluation of The Antibacterial Effect of Laser Diode and Zinc Oxide Nano-particles on Streptococcus Mutans Bacteria Used as Cavity Disinfectants in Deep Carious Lesions : A Randomized Controlled Clinical Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
this is a randomized controlled clinical trial, evaluating the antibacterial effect of laser diode and zinc oxide nano-particles when used as cavity disinfectants.Two groups, including 15 patients each, will be randomly allocated so that each group receives one of either interventions (15 patients will undergo cavity disinfection by laser diode, while the other 15 patients will undergo cavity disinfection by zinc oxide nano-particles). For each patient, a dentin sample will be taken before and after cavity disinfection. The dentin samples will be microbiologically analyzed to assess the difference in the bacterial count (out come assessment). The results will be statistically analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedMarch 27, 2018
March 1, 2018
10 months
March 18, 2018
March 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the bacterial Count (Streptococcus Mutans) CFU/ml after cavity disinfection
Samples of carious dentine will be collected with sterile excavator before and after application of both interventions. The dentine samples will be transferred to sterile container containing a 1mL thioglycollate medium used as a carrier, then this sterile container will be kept in an ice box and taken to the microbiology laboratory for processing, within an hour, by another examiner who is blinded to the type of agent applied after partial caries removal. Samples will be vortexed for two minutes, decimally diluted and 0.1 ml will be plated on Mitis Salivarius Bacitracin agar plates, these plates will be incubated anaerobically for 48 hour at 37ºC then aerobically for 24 hour at room temperature. The number of colonies will be expressed as colony-forming units (CFU/ml) compared before and after application of the antibacterial agent.
About one year
Study Arms (2)
zinc oxide nano-particles
EXPERIMENTALThe zinc oxide nano-powder will be mixed with ethanol and applied in the cavity, where the ethanol evaporates, while the zinc oxide nano-particles infiltrate into the carious floor of the cavity.
laser diode
EXPERIMENTALEach cavity will be irradiated in contact mode with continuous wave of radiation. The laser light is transferred through a 600µm flexible fiber optic tip by a special hand piece. The fiber optic will be disinfected for each use by 70% ethyl alcohol and inserted inside the cavity to 1mm with a spiral continuous movement clockwise from the top to the floor and anti-clockwise in the reverse direction. This procedure improves the distribution of the laser light inside the cavity and to avoid excessive heat generation in the internal cavity surface. Irradiation time will be 15 seconds and repeated 5 times with 15 second intervals with contact, according to manufacture instructions. During this study the output power will be adjusted at 1.5W.
Interventions
The zinc oxide nano-powder will be mixed with ethanol
The laser light is transferred through a 600µm flexible fiber optic tip by a special hand piece. the output power will be adjusted at 1.5W.
Eligibility Criteria
You may qualify if:
- Normal adults will be recruited in this study, with free medical history
- Have not received antibiotic therapy since 1 month before sampling
- Good oral hygiene
- Co-operative patients approving the trial
- In each patient required one or two deeply carious class v cavities either upper or lower permanent anterior teeth
You may not qualify if:
- Subjects with a history of allergy to any of the drugs or chemicals used in the study
- History of pulp pathology of the teeth which indicates root canal treatment is not included in the study
- Pregnancy and Lactating mothers
- Patients with any systematic problems or mental or physical disability
- Heavy smoking
- Xerostomia
- Lack of compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
sarah Atef khattab
Cairo, Maadi, Egypt
Related Publications (1)
Mohan PV, Uloopi KS, Vinay C, Rao RC. In vivo comparison of cavity disinfection efficacy with APF gel, Propolis, Diode Laser, and 2% chlorhexidine in primary teeth. Contemp Clin Dent. 2016 Jan-Mar;7(1):45-50. doi: 10.4103/0976-237X.177110.
PMID: 27041900BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mona I Riad, professor
Cairo University
- STUDY DIRECTOR
Rasha Raafat, lecturer
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- the examiner who will carry the microbiological analysis of dentin samples will be blinded to the type of agent applied during treatment. Finally, the treatment results will be assessed blindly by a statistician. Blinding: Blinding of the operator is not possible, because the natures of both interventions are obviously different. The operator is blinded until randomization into groups, to avoid biases with regard to the application of antibacterial agent. Also, the examiner who will carry the microbiological analysis of dentin samples will be blinded to the type of agent applied during treatment. Finally, the treatment results will be assessed blindly by a statistician also to avoid the risk of bias of results in favor of one intervention over the other.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master student at the department of conservative and aesthetic dentistry
Study Record Dates
First Submitted
March 18, 2018
First Posted
March 27, 2018
Study Start
April 1, 2018
Primary Completion
February 1, 2019
Study Completion
February 28, 2019
Last Updated
March 27, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share