Clinical, Microbiological and Biochemical Effects of the Antimicrobial Photodynamic Therapy

NCT01532674 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-02-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ondine Research Laboratories

    collaborator INDUSTRY
  • Spanish Society of Periodontology and Osseointegration ( SEPA)

    collaborator UNKNOWN
  • Francisco Alpiste Illueca

    lead OTHER

Principal Investigators

  • Alpiste Illueca Francisco, Professor · University of Valencia

  • Segarra vidal marta, postgraduate · University of Valencia

  • López Roldán Andrés, Professor · University of Valencia

  • Puchades Rufino Juan, professor · University of Valencia

  • gil loscos francisco, professor · University of Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01532674 on ClinicalTrials.gov