Back to resultsClinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy
Primary Purpose
Chronic Periodontitis
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Antimicrobial photodynamic therapy (Periowave) and scaling and root planing
scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Chronic generalized moderate-advanced periodontitis: based on "Classification System for Periodontal Diseases and Conditions" Armitage 1999. (24).Extension of the 30 % of affected zones. Severity base on clinical attachment loss: moderate = 3-4 mm of CAL, severe= > or equal 5 mm CAL.
- The subject is diagnosed with moderate or advanced chronic periodontitis.
- The subject has at least 4 sites with PD of ≥5 mm + bleeding in at least two quadrants of the mouth.
- A signed Informed Consent will be obtained.
- The subject is an adult male or female > 18 years of age.
- The subject has >18 fully erupted teeth, at least 3 teeth in each quadrant with one or more posterior teeth per quadrant (3º molars excluded).
- The subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study.
Exclusion Criteria:
- The subject is pregnant or nursing or plans to become pregnant in the next 6 months.
- The subject is a current smoker.
- The subject has an active malignancy of any type by subject report.
- The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol.
- The subject has any significant chronic disease (either acute or chronic) or who is taking a medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of the study.
- The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
- The subject has been treated with antibiotics within the 3-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc.) by report of the subject.
- The subject has a known allergy to Methylene Blue, polimetil metacrilate or chlorhexidine.
- The subject Has severe glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report.
- The subject currently uses anti-coagulant therapy at therapeutic doses.
- The subject is currently using any photosensitizing medications.
- Patients who have received SRP or Periodontal supportive therapy in the last 6 months
- It is considered > 30% of plaque of an index of 2 or more in the Silness y Löe plaque index the patient in the study.
Sites / Locations
- University of ValenciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Antimicrobial photodynamic therapy
scaling and root planing
Arm Description
Antimicrobial photodynamic therapy and scaling and root planing
Only scaling and root planing
Outcomes
Primary Outcome Measures
Improvement in Clinical Attachment Level
Secondary Outcome Measures
Improvement in Periodontal Pocket Depth
Improvement in Bleeding on Probing
Levels of IL-1
levels of IL-6
Levels of FNT-alfa
Levels of RANKL-OPJ.
Full Information
NCT ID
NCT01532674
First Posted
November 9, 2011
Last Updated
February 16, 2012
Sponsor
Francisco Alpiste Illueca
Collaborators
Ondine Research Laboratories, Spanish Society of Periodontology and Osseointegration ( SEPA)
1. Study Identification
Unique Protocol Identification Number
NCT01532674
Brief Title
Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy
Official Title
Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Alpiste Illueca
Collaborators
Ondine Research Laboratories, Spanish Society of Periodontology and Osseointegration ( SEPA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to determine if patients with chronic periodontitis when undergoing with scaling and root planing (SRP) plus photodynamic therapy in comparison with SRP alone result in improved clinical, microbiological and biochemical outcomes.
Detailed Description
This research is orientated to find an effective way to kill oral microorganisms that cause periodontitis and gingivitis with no problems of resistance, as it happens when we use antibiotics. The efficacy of this low power laser has been demonstrated in numerous fields in medicine and have been use it for years. The application of the photodynamic therapy is easy since we only have to fill the periodontal pocket with the photosensitive agent and apply the low power laser in that area. The photosensitive agent stain the bacteria immediately and the laser disrupts its membrane by a free-radical reaction. Improving the health status of the patients in a few weeks after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antimicrobial photodynamic therapy
Arm Type
Experimental
Arm Description
Antimicrobial photodynamic therapy and scaling and root planing
Arm Title
scaling and root planing
Arm Type
Active Comparator
Arm Description
Only scaling and root planing
Intervention Type
Device
Intervention Name(s)
Antimicrobial photodynamic therapy (Periowave) and scaling and root planing
Other Intervention Name(s)
Periowave
Intervention Description
ROOT PLANNING PROCEDURE:
The procedure is the same as in the control group
APPLICATION PROCEDURES OF THE PHOTOSENSITIZING AGENT :
The photosensitive agent : Formulation Periowave Treatment Kit-2ml
Application of the photosensitive using a blunt needle at the bottom of the periodontal pocket with circular movements covering the entire perimeter of the tooth.
Application of diode laser with a peak of 8.5 cm. long with a curvature of 60 degrees and flexible. Making a move in and out from the apical region to the more coronal region of the periodontal pocket. Each tooth has a working time of 60 seconds.
All the periodontal pockets will be treated subgingivally
Elimination of the photosensitive by irrigation
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Description
ROOT PLANNING PROCEDURE:
An unique operator ( independent from the explorer) will do the root planing for both the test and control group.
Every procedure will be done under local anaesthesia: Ultracain with Epinephrine 40/0,01 mg/ml. NORMON. It will be done a first session of root planning in the first and forth quadrant and in a 48 hours the root planning of the second and the third quadrant will be done. Every session wil be done with this material: Ultrasonic: Satelec suprasson p5 with ultrasonic tip H3, manual scalers: HU-FRIEDY 1/2, 7/8, 11/12, 13/14, 13/14 columbia.
* The session will finish as soon as the operator have removed all the supragingival and subgingival calculus and plaque.
Primary Outcome Measure Information:
Title
Improvement in Clinical Attachment Level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement in Periodontal Pocket Depth
Time Frame
6 months
Title
Improvement in Bleeding on Probing
Time Frame
6 months
Title
Levels of IL-1
Time Frame
6 months.
Title
levels of IL-6
Time Frame
6 months
Title
Levels of FNT-alfa
Time Frame
6 months
Title
Levels of RANKL-OPJ.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chronic generalized moderate-advanced periodontitis: based on "Classification System for Periodontal Diseases and Conditions" Armitage 1999. (24).Extension of the 30 % of affected zones. Severity base on clinical attachment loss: moderate = 3-4 mm of CAL, severe= > or equal 5 mm CAL.
The subject is diagnosed with moderate or advanced chronic periodontitis.
The subject has at least 4 sites with PD of ≥5 mm + bleeding in at least two quadrants of the mouth.
A signed Informed Consent will be obtained.
The subject is an adult male or female > 18 years of age.
The subject has >18 fully erupted teeth, at least 3 teeth in each quadrant with one or more posterior teeth per quadrant (3º molars excluded).
The subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study.
Exclusion Criteria:
The subject is pregnant or nursing or plans to become pregnant in the next 6 months.
The subject is a current smoker.
The subject has an active malignancy of any type by subject report.
The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol.
The subject has any significant chronic disease (either acute or chronic) or who is taking a medication with concomitant oral manifestations that in the opinion of the investigator would interfere with evaluation of safety or efficacy of the study.
The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
The subject has been treated with antibiotics within the 3-month period prior to beginning the study or any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements, etc.) by report of the subject.
The subject has a known allergy to Methylene Blue, polimetil metacrilate or chlorhexidine.
The subject Has severe glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report.
The subject currently uses anti-coagulant therapy at therapeutic doses.
The subject is currently using any photosensitizing medications.
Patients who have received SRP or Periodontal supportive therapy in the last 6 months
It is considered > 30% of plaque of an index of 2 or more in the Silness y Löe plaque index the patient in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alpiste Francisco, Professor
Phone
963983136
Ext
011 34
Email
francisco.alpiste@uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alpiste Illueca Francisco, Professor
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Segarra vidal marta, postgraduate
Organizational Affiliation
University of Valencia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
López Roldán Andrés, Professor
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Puchades Rufino Juan, professor
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
gil loscos francisco, professor
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Segarra Marta, Postgraduate
Phone
653838086
Ext
011 34
Email
marta_segarra_vidal@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy
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