Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

NCT ID: NCT01532674

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antimicrobial photodynamic therapy

Antimicrobial photodynamic therapy and scaling and root planing

Group Type: EXPERIMENTAL

Antimicrobial photodynamic therapy (Periowave) and scaling and root planing

Intervention Type: DEVICE

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

scaling and root planing

Only scaling and root planing

Group Type: ACTIVE_COMPARATOR

scaling and root planing

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Periowave

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ondine Research Laboratories

INDUSTRY

Sponsor Role: collaborator

Spanish Society of Periodontology and Osseointegration ( SEPA)

UNKNOWN

Sponsor Role: collaborator

Francisco Alpiste Illueca

OTHER

Sponsor Role: lead

Responsible Party

Francisco Alpiste Illueca

University Professor of University of Valencia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alpiste Illueca Francisco, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Segarra vidal marta, postgraduate

Role: STUDY_DIRECTOR

University of Valencia

López Roldán Andrés, Professor

Role: STUDY_CHAIR

University of Valencia

Puchades Rufino Juan, professor

Role: STUDY_CHAIR

University of Valencia

gil loscos francisco, professor

Role: STUDY_CHAIR

University of Valencia

Locations

University of Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alpiste Francisco, Professor

Role: CONTACT

francisco.alpiste@uv.es

963983136 ext. 011 34

Facility Contacts

Segarra Marta, Postgraduate

Role: primary

marta_segarra_vidal@hotmail.com

653838086 ext. 011 34

Other Identifiers

UV1

Identifier Type: -

Identifier Source: org_study_id