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Completed

NCT Number: NCT01670305

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of dentistry - Paulista University UNIP

São Paulo, Brazil

About this study

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

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Residual pockets will be treated by laser + photosensitizer

Procedure

Experimental group: Residual pockets will be treated by laser + photosensitizer

Residual pockets will be treated only photosensitizer

Procedure

Placebo Comparator: Residual pockets will be treated only photosensitizer

Residual pockets will be treated scaling and root planing

Procedure

Active Comparator: Residual pockets will be treated scaling and root planing

laser + photosensitizer associated with scaling and root planing

Procedure

Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing

furcation defects will be treated by scaling and root planing

Procedure

Active Comparator: furcation defects will be treated by scaling and root planing

Primary outcomes

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

    Time frame: baseline, 3 and 6 months post-therapies

Secondary outcomes

  1. Probing Pocket depth

    Time frame: baseline, 3 and 6 months post-therapies.

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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