NCT01532674

Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Francisco Alpiste Illueca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-02-14
• Last updated: 2012-02-20

Locations

1 site across 1 country: Spain