Antibacterial Effect of Diode LaserNCT03298165
The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .
A study testing diode laser in people with Antibacterial Effect of Diode Laser, run by Cairo University.
Trial summary
This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibacterial Effect of Diode Laser
- What is being tested?
- diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with at least two deep occlusal carious lesion .
- 18 - 25years.
- Males or Females.
- Good oral hygiene.
- Co-operative patients approving the trial and willing to sign a written consent.
Who cannot join
- Pregnancy.
- Systemic disease or severe medical complications.
- Heavy smoking.
- Xerostomia.
- Lack of compliance.
- Evidence of temporomandibular joint disorders.
About this study
Official title: Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).
This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.
Read the detailed description
each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.
A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .
In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored
- Conditions
- Antibacterial Effect of Diode Laser
- Being tested
- diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diode laserDevice
diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation
| Study group | Role | What they receive |
|---|---|---|
| disinfection the cavity with diode laser | Experimental | diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation Receives: Device: diode laser |
| no cavity disinfection | Placebo comparator | placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed . Receives: Device: diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacteriological count
dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study startFeb 2018 (estimated)
- Primary completion15 Mar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibacterial Effect of Diode LaserStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shahenda gamal tawfik hamdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298165
- Sponsor's protocol ID
- cebc-cu-2017-09-25
- Status last verified
- Jan 2018
- First submitted
- 27 Sep 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).
- ClinicalTrials.gov ID
- NCT03298165
- Acronym / sponsor ID
- cebc-cu-2017-09-25
- Conditions
- Antibacterial Effect of Diode Laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.
Detailed description
each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.
A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .
In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| disinfection the cavity with diode laser | Experimental | Device: diode laserdiode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation |
| no cavity disinfection | Placebo comparator | Device: diode laserplacebo is used as no cavity disinfection will be done as after excavation the restoration will be placed . |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with at least two deep occlusal carious lesion .
- 18 - 25years.
- Males or Females.
- Good oral hygiene.
- Co-operative patients approving the trial and willing to sign a written consent.
Key exclusion criteria (6 listed)
- Pregnancy.
- Systemic disease or severe medical complications.
- Heavy smoking.
- Xerostomia.
- Lack of compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diode laserdiode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation | Device | disinfection the cavity with diode laser, no cavity disinfection |
Primary outcome
bacteriological count
Time frame: 30 minute
dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing diode laser in people with Antibacterial Effect of Diode Laser, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacteriological count (time frame: 30 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018; AzTrials last refreshed its copy on 6 Nov 2026.