Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Valencia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ondine Research Laboratories
Spanish Society of Periodontology and Osseointegration ( SEPA)
Information provided by (Responsible Party):
Francisco Alpiste Illueca, University of Valencia
ClinicalTrials.gov Identifier:
NCT01532674
First received: November 9, 2011
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Chronic Periodontitis
Device: Antimicrobial photodynamic therapy (Periowave) and scaling and root planing
Procedure: scaling and root planing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Improvement in Clinical Attachment Level [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in Periodontal Pocket Depth [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Improvement in Bleeding on Probing [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Levels of IL-1 [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]
  • levels of IL-6 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Levels of FNT-alfa [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Levels of RANKL-OPJ. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532674

Contacts
Contact: Alpiste Francisco, Professor 963983136 ext 011 34 francisco.alpiste@uv.es

Locations
Spain
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Segarra Marta, Postgraduate    653838086 ext 011 34    marta_segarra_vidal@hotmail.com   
Sponsors and Collaborators
Francisco Alpiste Illueca
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
  More Information

No publications provided

Responsible Party: Francisco Alpiste Illueca, University Professor of University of Valencia, University of Valencia
ClinicalTrials.gov Identifier: NCT01532674     History of Changes
Other Study ID Numbers: UV1
Study First Received: November 9, 2011
Last Updated: February 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014