Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

NCT01532674 | Unknown Phase 4 DMC

• 1 other identifier: UV1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Improvement in Clinical Attachment Level

  6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Antimicrobial photodynamic therapy

EXPERIMENTAL

Antimicrobial photodynamic therapy and scaling and root planing

Device: Antimicrobial photodynamic therapy (Periowave) and scaling and root planing

scaling and root planing

ACTIVE COMPARATOR

Only scaling and root planing

Procedure: scaling and root planing

Interventions

Antimicrobial photodynamic therapy (Periowave) and scaling and root planing 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

Also known as: Periowave

Antimicrobial photodynamic therapy

scaling and root planing 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.

scaling and root planing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Alpiste Illueca: lead
• Ondine Research Laboratories: collaborator
• Spanish Society of Periodontology and Osseointegration ( SEPA): collaborator

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Root Planing; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Alpiste Illueca Francisco, Professor

  University of Valencia

  PRINCIPAL INVESTIGATOR

• Segarra vidal marta, postgraduate

  University of Valencia

  STUDY DIRECTOR

• 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 CHAIR

Central Study Contacts

Alpiste Francisco, Professor

CONTACT

963983136; francisco.alpiste@uv.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Professor of University of Valencia

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: February 14, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 20, 2012

Record last verified: 2012-02

Locations

ES (1)