Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Device: Antimicrobial photodynamic therapy (Periowave) and scaling and root planing; Procedure: scaling and root planing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alpiste Francisco, Professor; Phone Number: 011 34 963983136; Email: francisco.alpiste@uv.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Recruiting
    • University of Valencia
    • Contact: Segarra Marta, Postgraduate; Phone Number: 011 34 653838086; Email: marta_segarra_vidal@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. The subject is diagnosed with moderate or advanced chronic periodontitis.
3. The subject has at least 4 sites with PD of ≥5 mm + bleeding in at least two quadrants of the mouth.
4. A signed Informed Consent will be obtained.
5. The subject is an adult male or female > 18 years of age.
6. 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).
7. The subject is willing and able to return for treatment and evaluation procedures scheduled throughout the course of this clinical study.

Exclusion Criteria:

1. The subject is pregnant or nursing or plans to become pregnant in the next 6 months.
2. The subject is a current smoker.
3. The subject has an active malignancy of any type by subject report.
4. The subject has chronic disease or diminished mental capacity that would mitigate the ability to comply with the protocol.
5. 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.
6. The subject has an active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis.
7. 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.
8. The subject has a known allergy to Methylene Blue, polimetil metacrilate or chlorhexidine.
9. The subject Has severe glucose-6-phosphate dehydrogenase (G6PD) deficiency by subject report.
10. The subject currently uses anti-coagulant therapy at therapeutic doses.
11. The subject is currently using any photosensitizing medications.
12. Patients who have received SRP or Periodontal supportive therapy in the last 6 months
13. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antimicrobial photodynamic therapy; Antimicrobial photodynamic therapy and scaling and root planing	Device: Antimicrobial photodynamic therapy (Periowave) and scaling and root planing; 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; Other Names: Periowave
Active Comparator: scaling and root planing; Only scaling and root planing	Procedure: scaling and root planing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Clinical Attachment Level	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in Periodontal Pocket Depth	6 months
Improvement in Bleeding on Probing	6 months
Levels of IL-1	6 months.
levels of IL-6	6 months
Levels of FNT-alfa	6 months
Levels of RANKL-OPJ.	6 months

Collaborators and Investigators

• Sponsor: Francisco Alpiste Illueca
• Collaborators: Ondine Research Laboratories; Spanish Society of Periodontology and Osseointegration ( SEPA)
• Investigators: Principal Investigator: Alpiste Illueca Francisco, Professor, University of Valencia; Study Director: Segarra vidal marta, postgraduate, University of Valencia; Study Chair: López Roldán Andrés, Professor, University of Valencia; Study Chair: Puchades Rufino Juan, professor, University of Valencia; Study Chair: gil loscos francisco, professor, University of Valencia

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 14, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2012
• Last Update Submitted That Met QC Criteria: February 16, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: UV1