Adjunctive Photodynamic Therapy in the Treatment of Chronic Periodontitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Tehran University of Medical Sciences.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Tehran University of Medical Sciences
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01330082
First received: April 4, 2011
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
The aim of this randomized clinical trial is to clinically evaluate the effectiveness of the adjunctive use of photodynamic therapy (PDT) with an light-emitting diode (LED) light source in the treatment of chronic periodontitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Periodontitis |
Other: Adjunctive Photodynamic Therapy Other: Light-emitting diod Irradiation Other: applying Photosensitizer |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Adjunctive Photodynamic Therapy Using Light-emitting Diode in the Treatment of Chronic Periodontitis |
Further study details as provided by Tehran University of Medical Sciences:
Primary Outcome Measures:
- Probing pocket depth [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]distance from gingival margin to base of the clinical pocket by William`s periodontal probe
Secondary Outcome Measures:
- Clinical attachment loss [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]distance in millimeter from a fix reference point (cement-enamel junction) to the bottom of probable pocket at experimental sites
- Bleeding upon probing [ Time Frame: Baseline, one month, three month ] [ Designated as safety issue: No ]presence or the absence of bleeding up to 30 second after probing with a William`s periodontal probe
- plaque index [ Time Frame: Baseline,before PDT procedure, one month, three month ] [ Designated as safety issue: No ]teeth number 16,12,24,36,32,44 are evaluated according to silness plaque index instruction were scored between 0 to 3
| Enrollment: | 16 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Photodynamic therapy
will be treated by PDT using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
|
Other: Adjunctive Photodynamic Therapy
using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
|
|
Experimental: Light-emitting diode Irradiation
will be treated only by using Light-emitting diode(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark)
|
Other: Light-emitting diod Irradiation
625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
|
|
Experimental: applying photosensitizer
will be treated only by toluidine blue O
|
Other: applying Photosensitizer
toluidine blue O is applied at the bottom of each periodontal pocket
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- clinically diagnosis of advanced chronic periodontitis with more than 3 mm clinical attachment loss
- presence of at least two teeth with probing depth of 4 to 6 mm without furcation involvement in each quadrant
- at least 16 remaining teeth
- no periodontal treatment in the past 12 months
- no evidence of systemic disease related to periodontal problems
- no use of antibiotics for the past 6 months
- No smoking more than 10 cigarettes per day
- no addiction to any kind of drugs
- no pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330082
Locations
| Iran, Islamic Republic of | |
| Tehran University of Medical Sciences | |
| Tehran, Iran, Islamic Republic of, 141555583 | |
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
| Study Chair: | Neda Moslemi, DDS,MS | Tehran University of Medical Sciences |
| Principal Investigator: | Seyed Hossein Bassir, DDS | Tehran University of Medical Sciences |
More Information
No publications provided
| Responsible Party: | Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01330082 History of Changes |
| Other Study ID Numbers: | 09123209916 |
| Study First Received: | April 4, 2011 |
| Last Updated: | April 5, 2011 |
| Health Authority: | Iran: Tehran University of Medical Sciences |
Keywords provided by Tehran University of Medical Sciences:
|
Photodynamic therapy Light-emitting diode toluidine blue scaling and root planing |
Additional relevant MeSH terms:
|
Periodontitis Chronic Periodontitis Periodontal Diseases Mouth Diseases Stomatognathic Diseases Tolonium Chloride Photosensitizing Agents Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Heparin Antagonists Molecular Mechanisms of Pharmacological Action Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013