Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
sham procedure
photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring periodontitis, photodynamic therapy
Eligibility Criteria
Inclusion Criteria:
- Chronic Periodontitis (Tonetti, Claffey, 2005)
- 10 or more teeth
- 2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation
Exclusion Criteria:
- Profilatic antibiotics
- Diabetes, immunosuppression, pregnancy nursing mother
- Smoking
- Medication that might interfere with periodontal healing
- Previous periodontal treatment or antibiotics (6 months)
- Experimental teeth with mobility II or III, or endodontic problem
Sites / Locations
- Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
photodynamic therapy
sham procedure
Arm Description
photodynamic therapy 660 nm,40 mW,60 Hz
Not activation of laser device
Outcomes
Primary Outcome Measures
Change in mean attachment level
Secondary Outcome Measures
Change in probing pocket depth
Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.
Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)
Full Information
NCT ID
NCT01034501
First Posted
December 16, 2009
Last Updated
October 9, 2013
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01034501
Brief Title
Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis
Official Title
Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham
Detailed Description
The goal of periodontal treatment is to restore tissue health through the elimination and control of etiologic factors, reducing the microbial aggression. Some microorganisms persist in the root surface even after scraping. Thus, the conventional mechanical treatment may fail to reduce the number of periodontal pathogens to levels compatible with health. This study will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
periodontitis, photodynamic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
photodynamic therapy
Arm Type
Active Comparator
Arm Description
photodynamic therapy 660 nm,40 mW,60 Hz
Arm Title
sham procedure
Arm Type
Sham Comparator
Arm Description
Not activation of laser device
Intervention Type
Device
Intervention Name(s)
sham procedure
Other Intervention Name(s)
Laser Hand - MM Optics (ANVISA: 80051420009)
Intervention Description
non activated laser tip
Intervention Type
Device
Intervention Name(s)
photodynamic therapy
Other Intervention Name(s)
Laser Hand - MM Optics (ANVISA: 80051420009)
Intervention Description
photodynamic therapy 660 nm,40 mW,60 Hz
Primary Outcome Measure Information:
Title
Change in mean attachment level
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in probing pocket depth
Time Frame
12 months
Title
Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.
Time Frame
12 months
Title
Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Periodontitis (Tonetti, Claffey, 2005)
10 or more teeth
2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation
Exclusion Criteria:
Profilatic antibiotics
Diabetes, immunosuppression, pregnancy nursing mother
Smoking
Medication that might interfere with periodontal healing
Previous periodontal treatment or antibiotics (6 months)
Experimental teeth with mobility II or III, or endodontic problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio De Micheli, Professor
Organizational Affiliation
FOUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Odontologia da Universidade de São Paulo (FOUSP)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18771363
Citation
Christodoulides N, Nikolidakis D, Chondros P, Becker J, Schwarz F, Rossler R, Sculean A. Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial. J Periodontol. 2008 Sep;79(9):1638-44. doi: 10.1902/jop.2008.070652.
Results Reference
background
PubMed Identifier
18713259
Citation
Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17.
Results Reference
background
PubMed Identifier
25808980
Citation
Carvalho VF, Andrade PV, Rodrigues MF, Hirata MH, Hirata RD, Pannuti CM, De Micheli G, Conde MC. Antimicrobial photodynamic effect to treat residual pockets in periodontal patients: a randomized controlled clinical trial. J Clin Periodontol. 2015 May;42(5):440-7. doi: 10.1111/jcpe.12393. Epub 2015 Apr 22.
Results Reference
derived
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Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis
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