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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • School of dentistry - Paulista University UNIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Clinical attachment level at 3 and 6 months.	baseline, 3 and 6 months post-therapies

Secondary Outcome Measures

Outcome Measure	Time Frame
Probing Pocket depth	baseline, 3 and 6 months post-therapies.

Collaborators and Investigators

• Sponsor: Paulista University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 22, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Dermatologic Agents; Photosensitizing Agents
• Other Study ID Numbers: 0272.0.251.000-10