Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcio Zaffalon Casati, Paulista University
ClinicalTrials.gov Identifier:
NCT01670305
First received: June 13, 2012
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

Residual pockets and furcation defects are challenging sites that require additional periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with scaling and root planing (SRP) in class II furcation lesions with probing pocket depth (PPD) >5mm and bleeding on probing (BoP). A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation defect. To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed at baseline, 3 and 6 months post-therapies.


Condition Intervention
Periodontal Disease
Procedure: Residual pockets will be treated by laser + photosensitizer
Procedure: Residual pockets will be treated only photosensitizer
Procedure: Residual pockets will be treated scaling and root planing
Procedure: laser + photosensitizer associated with scaling and root planing
Procedure: furcation defects will be treated by scaling and root planing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis.

Further study details as provided by Paulista University:

Primary Outcome Measures:
  • Change from baseline in Clinical attachment level at 3 and 6 months. [ Time Frame: baseline, 3 and 6 months post-therapies ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Probing Pocket depth [ Time Frame: baseline, 3 and 6 months post-therapies. ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Residual pocket - PDT
Photosensitizer plus diiodo laser
Procedure: Residual pockets will be treated by laser + photosensitizer
Experimental group: Residual pockets will be treated by laser + photosensitizer
Placebo Comparator: Residual pocket - Photosensitizer
Photosensitizer alone
Procedure: Residual pockets will be treated only photosensitizer
Placebo Comparator: Residual pockets will be treated only photosensitizer
Active Comparator: Residual pocket - SRP
scaling and root planing alone
Procedure: Residual pockets will be treated scaling and root planing
Active Comparator: Residual pockets will be treated scaling and root planing
Experimental: Furcation - PDT+SRP
Photosensitizer plus diiodo laser associated with scaling and root planing
Procedure: laser + photosensitizer associated with scaling and root planing
Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing
Active Comparator: Furcation - SRP
Photosensitizer associated with scaling and root planing
Procedure: furcation defects will be treated by scaling and root planing
Active Comparator: furcation defects will be treated by scaling and root planing

Detailed Description:

Residual pockets and class II furcation lesions are challenging sites that require additional periodontal therapy. The aims of this study were to evaluate:

1) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT in association with SRP in class II furcation lesions.

A blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class II furcation involvement.

To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP alone.

To evaluate the effect of PDT in association with SRP in class II furcation lesions, the selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological, immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS) and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of chronic periodontitis (according to the criteria of the 1999 international classification)
  • at least three contralateral single rooted teeth with residual PPD > 5mm with bleeding on probing (BoP) in supportive periodontal therapy or with at least one molar presenting class II furcation defect.

Exclusion Criteria:

  • pregnancy
  • lactation
  • current smoking and smoking within the past 10 years
  • antibiotic therapies in the previous 6 months
  • use of mouth rinses containing antimicrobials in the preceding 2 months
  • systemic conditions that could affect the progression of periodontitis
  • orthodontic appliances
  • use of long-term administration of anti-inflammatory and immunosuppressive medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670305

Locations
Brazil
School of dentistry - Paulista University UNIP
São Paulo, SP, Brazil
Sponsors and Collaborators
Paulista University
  More Information

Additional Information:
No publications provided

Responsible Party: Marcio Zaffalon Casati, Professor, Paulista University
ClinicalTrials.gov Identifier: NCT01670305     History of Changes
Other Study ID Numbers: 0272.0.251.000-10
Study First Received: June 13, 2012
Last Updated: September 10, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014