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

Primary Purpose

Periodontal Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Residual pockets will be treated by laser + photosensitizer
Residual pockets will be treated only photosensitizer
Residual pockets will be treated scaling and root planing
laser + photosensitizer associated with scaling and root planing
furcation defects will be treated by scaling and root planing
Sponsored by
Paulista University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • School of dentistry - Paulista University UNIP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

Residual pocket - PDT

Residual pocket - Photosensitizer

Residual pocket - SRP

Furcation - PDT+SRP

Furcation - SRP

Arm Description

Photosensitizer plus diiodo laser

Photosensitizer alone

scaling and root planing alone

Photosensitizer plus diiodo laser associated with scaling and root planing

Photosensitizer associated with scaling and root planing

Outcomes

Primary Outcome Measures

Change from baseline in Clinical attachment level at 3 and 6 months.

Secondary Outcome Measures

Probing Pocket depth

Full Information

First Posted
June 13, 2012
Last Updated
September 10, 2013
Sponsor
Paulista University
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1. Study Identification

Unique Protocol Identification Number
NCT01670305
Brief Title
Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis
Official Title
Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Residual pocket - PDT
Arm Type
Experimental
Arm Description
Photosensitizer plus diiodo laser
Arm Title
Residual pocket - Photosensitizer
Arm Type
Placebo Comparator
Arm Description
Photosensitizer alone
Arm Title
Residual pocket - SRP
Arm Type
Active Comparator
Arm Description
scaling and root planing alone
Arm Title
Furcation - PDT+SRP
Arm Type
Experimental
Arm Description
Photosensitizer plus diiodo laser associated with scaling and root planing
Arm Title
Furcation - SRP
Arm Type
Active Comparator
Arm Description
Photosensitizer associated with scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
Residual pockets will be treated by laser + photosensitizer
Intervention Description
Experimental group: Residual pockets will be treated by laser + photosensitizer
Intervention Type
Procedure
Intervention Name(s)
Residual pockets will be treated only photosensitizer
Intervention Description
Placebo Comparator: Residual pockets will be treated only photosensitizer
Intervention Type
Procedure
Intervention Name(s)
Residual pockets will be treated scaling and root planing
Intervention Description
Active Comparator: Residual pockets will be treated scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
laser + photosensitizer associated with scaling and root planing
Intervention Description
Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
furcation defects will be treated by scaling and root planing
Intervention Description
Active Comparator: furcation defects will be treated by scaling and root planing
Primary Outcome Measure Information:
Title
Change from baseline in Clinical attachment level at 3 and 6 months.
Time Frame
baseline, 3 and 6 months post-therapies
Secondary Outcome Measure Information:
Title
Probing Pocket depth
Time Frame
baseline, 3 and 6 months post-therapies.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
School of dentistry - Paulista University UNIP
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www3.unip.br/default.asp
Description
Related Info

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

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