Pilot Study,Diode Laser 808 nm Supported Direct Pulp Capping in Permanent Teeth (Laser in DPC)

July 24, 2013 updated by: iraj yazdanfar, Yazdanfar, Iraj, M.D.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  1. Permanent teeth with deep caries
  2. Vitality of teeth
  3. No peri-apical radiographic changes
  4. Acceptance research program

Exclusion Criteria:

  1. Symptoms
  2. Peri-apical radiographic changes
  3. No stopped bleeding within 3 minutes after exposure
  4. No acceptance study program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yazdanfar, Iraj, M.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • private practice

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain Reduction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings