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

Not Applicable

Completed

• Conditions: Periodontal Disease
• Interventions: Procedure: laser + photosensitizer associated with scaling and root planing; 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: furcation defects will be treated by scaling and root planing

• Registration Number: NCT01670305
• Lead Sponsor: Paulista University

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-05
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-22
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furcation - PDT+SRP	laser + photosensitizer associated with scaling and root planing	Photosensitizer plus diiodo laser associated with scaling and root planing
Residual pocket - PDT	Residual pockets will be treated by laser + photosensitizer	Photosensitizer plus diiodo laser
Residual pocket - Photosensitizer	Residual pockets will be treated only photosensitizer	Photosensitizer alone
Residual pocket - SRP	Residual pockets will be treated scaling and root planing	scaling and root planing alone
Furcation - SRP	furcation defects will be treated by scaling and root planing	Photosensitizer associated with scaling and root planing

Primary Outcome Measures

Name	Time	Method
Change from baseline in Clinical attachment level at 3 and 6 months.	baseline, 3 and 6 months post-therapies

Secondary Outcome Measures

Name	Time	Method
Probing Pocket depth	baseline, 3 and 6 months post-therapies.

Trial Locations

Locations (1)

School of dentistry - Paulista University UNIP; 🇧🇷 São Paulo, SP, Brazil