HaemostaticLaser in DPCNCT01907919
Pilot Study,Diode Laser 808 nm Supported Direct Pulp Capping in Permanent Teeth
An observational study of Haemostatic and Bacterial De-contamination, run by Yazdanfar, Iraj, M.D..
Trial summary
The purpose of this study was to compare the conventional and diode 808 nm laser-assisted techniques in direct pulp capping in permanent teeth .The present study was based on a series of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this paper was laser supported direct pulp… Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemostatic, Bacterial De-contamination, Bio-stimulation
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Aug 2012
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study was carried out on 10 patients, aged between 12 and 40 years, with an average age of 26 years, who underwent conservative treatment for deep caries of permanent teeth (2 anterior and 8 posterior).
Who may be able to join
- Permanent teeth with deep caries
- Vitality of teeth
- No peri-apical radiographic changes
- Acceptance research program
Who cannot join
- Symptoms
- Peri-apical radiographic changes
- No stopped bleeding within 3 minutes after exposure
- No acceptance study program
About this study
Official title: Diode Laser-Assisted Direct Pulp Capping In Permanent Teeth
The purpose of this study was to compare the conventional and diode 808 nm laser-assisted techniques in direct pulp capping in permanent teeth .The present study was based on a series of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated areas, its ability in the fast and better haemostatic, and pain reduction.
- Conditions
- Haemostatic, Bacterial De-contamination, Bio-stimulation, Reparative Dentine Formation, Pain Reduction
- Keywords
- Pulp capping, Diode laser 808 nm, Tertiary dentin, RM-GIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conventional group,RM-GIC | 1. Group A: Five teeth were treated with traditional rotating instruments, the cavities were prepared with diamond drills by turbine, multiple-blade drills by headpiece for removing the decayed dentine and, after cleaning and control of bleeding with cotton pellets with saline solution,RM-GIC (3M ESPE, USA) light-hardening paste was placed gently on the exposed part of the pulp and cavity floor next final restoration with composite z350 flow able and p60 (3M ESPE, USA). | |
| Diode 808 nm laser-assisted group | 2. Group B : Five teeth cavities were prepared as the same with group one with traditional rotating instruments, hemostatic and cavities sterilization were achieved by a diode 808 nm (Picasso- AMD, USA) laser using following parameters: * Hemostatic: 1.5 W, CW, fiber diameter 400µm, in contact, 2s per 1mm, vertical and horizontal scanning movement on exposure site. * Cavity sterilization: 1W, CW, fiber diameter 400µm, in contact, 2mm per s, circular movement. After hemostatic and cavity sterilization, RM-GIC (3M ESPE, USA) light-hardening paste was placed on the exposed part of the pulp and cavity floor next final restoration with composite z350 flow able and p60 (3M ESPE, USA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of teeth vitality was be measured via thermal tests also by radiographic.
Given low success rate of conventional methods, new techniques as laser-assisted need to be developed.The outcome measure of this study was maintenance of teeth vitality with carious exposed via tertiary dentine formation.the tertiary dentine formation during the time of study was assessed radiological. Therefore vitality of the teeth was depend on dentine formation that was measured periodically in 1,6 and 12 months.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemostaticStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yazdanfar, Iraj, M.D.
- Collaborators
- RWTH Aachen University
- Responsible party
- Principal investigator, iraj yazdanfar, Yazdanfar, Iraj, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907919
- Sponsor's protocol ID
- private practice
- Acronym
- Laser in DPC
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diode Laser-Assisted Direct Pulp Capping In Permanent Teeth
- ClinicalTrials.gov ID
- NCT01907919
- Acronym / sponsor ID
- Laser in DPC / private practice
- Conditions
- Haemostatic, Bacterial De-contamination, Bio-stimulation, Reparative Dentine Formation, Pain Reduction
- Keywords
- Pulp capping, Diode laser 808 nm, Tertiary dentin, RM-GIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yazdanfar, Iraj, M.D.
- Collaborators
- RWTH Aachen University
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
The purpose of this study was to compare the conventional and diode 808 nm laser-assisted techniques in direct pulp capping in permanent teeth .The present study was based on a series of ten clinical studies with pulp exposure caused by carious lesions.The hypothesis of this paper was laser supported direct pulp cap-ping has proven effectiveness by its capacity to stimulate reparative dentine formation by pulp cells, de-contamination ability of irradiated areas, its ability in the fast and better haemostatic, and pain reduction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group,RM-GIC | – | –1. Group A: Five teeth were treated with traditional rotating instruments, the cavities were prepared with diamond drills by turbine, multiple-blade drills by headpiece for removing the decayed dentine and, after cleaning and control of bleeding with cotton pellets with saline solution,RM-GIC (3M ESPE, USA) light-hardening paste was placed gently on the exposed part of the pulp and cavity floor next final restoration with composite z350 flow able and p60 (3M ESPE, USA). |
| Diode 808 nm laser-assisted group | – | –2. Group B : Five teeth cavities were prepared as the same with group one with traditional rotating instruments, hemostatic and cavities sterilization were achieved by a diode 808 nm (Picasso- AMD, USA) laser using following parameters: * Hemostatic: 1.5 W, CW, fiber diameter 400µm, in contact, 2s per 1mm, vertical and horizontal scanning movement on exposure site. * Cavity sterilization: 1W, CW, fiber diameter 400µm, in contact, 2mm per s, circular movement. After hemostatic and cavity sterilization, RM-GIC (3M ESPE, USA) light-hardening paste was placed on the exposed part of the pulp and cavity floor next final restoration with composite z350 flow able and p60 (3M ESPE, USA). |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study was carried out on 10 patients, aged between 12 and 40 years, with an average age of 26 years, who underwent conservative treatment for deep caries of permanent teeth (2 anterior and 8 posterior).
Key inclusion criteria (4 listed)
- Permanent teeth with deep caries
- Vitality of teeth
- No peri-apical radiographic changes
- Acceptance research program
Key exclusion criteria (4 listed)
- Symptoms
- Peri-apical radiographic changes
- No stopped bleeding within 3 minutes after exposure
- No acceptance study program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maintenance of teeth vitality was be measured via thermal tests also by radiographic.
Time frame: up to 12 months
Given low success rate of conventional methods, new techniques as laser-assisted need to be developed.The outcome measure of this study was maintenance of teeth vitality with carious exposed via tertiary dentine formation.the tertiary dentine formation during the time of study was assessed radiological. Therefore vitality of the teeth was depend on dentine formation that was measured periodically in 1,6 and 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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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?
An observational study of Haemostatic and Bacterial De-contamination, run by Yazdanfar, Iraj, M.D..
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jul 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maintenance of teeth vitality was be measured via thermal tests also by radiographic. (time frame: up to 12 months). 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 Jul 2013.