Evaluation of the Antibacterial Effect of Laser Diode and Zinc Oxide Nano Particles in Cavity Disinfection
NCT ID: NCT03478150
Last Updated: 2018-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-04-01
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Evaluation and Microbiological Assessment of Diode Laser and Chemical Disinfection in Comparison to Selective Caries Removal
NCT03955341
The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .
NCT03298165
Effectiveness of Silver Diamine Fluoride as Cavity Disinfectant After Atraumatic Restorative Treatment in Primary Teeth
NCT03855527
Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity
NCT06967818
Comparison of Cariostatic Effect of Nano-Silver Fluoride Versus Silver Diamine Fluoride
NCT05941429
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A : Excavation protocol:
The teeth of the patients that meet inclusion criteria will be anaesthetized, isolated with a rubber dam. Cavity opened using conventional high-speed rotary instruments. The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs. Caries lesion will be completely removed in the enamel/dentin junction. The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring. A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment. Then, after application of either interventions , another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis.
b. Application of the interventions: b.1: laser diode Each 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 1 millimeter 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 1.5 Watt.
b.2: Zinc oxide nano-particles: The 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.
N.B: In both methods, a dentin sample will be taken before the application of the disinfectant, then the zinc oxide nano-particles are applied in the cavity and left for 5 minutes, then another sample will be taken. The second specimen will be compared to the first specimen taken before cavity disinfection, regarding the streptococcus mutans count.
c .Assessment of Outcome: Samples of carious dentin will be collected with sterile excavator before and after application of both interventions. The dentin samples will be transferred to sterile container containing a 1millilitre 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 37 degree celcius 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
zinc oxide nano-particles
The 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.
zinc oxide nano-particles
The zinc oxide nano-powder will be mixed with ethanol
laser diode
Each 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.
laser diode
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
zinc oxide nano-particles
The zinc oxide nano-powder will be mixed with ethanol
laser diode
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Atef Khattab
master student at the department of conservative and aesthetic dentistry
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mona I Riad, professor
Role: STUDY_CHAIR
Cairo University
Rasha Raafat, lecturer
Role: STUDY_DIRECTOR
Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
sarah Atef khattab
Cairo, Maadi, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
oper151
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.