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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01907919
Other study ID # private practice
Secondary ID
Status Completed
Phase N/A
First received July 12, 2013
Last updated July 24, 2013
Start date July 2011

Study information

Verified date July 2013
Source Yazdanfar, Iraj, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 40 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Yazdanfar, Iraj, M.D. RWTH Aachen University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 12 months Yes
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