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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670305
• Other study ID #: 0272.0.251.000-10
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: September 10, 2013
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Paulista University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Procedure:
• Residual pockets will be treated by laser + photosensitizer
Experimental group: Residual pockets will be treated by laser + photosensitizer
• Residual pockets will be treated only photosensitizer
Placebo Comparator: Residual pockets will be treated only photosensitizer
• Residual pockets will be treated scaling and root planing
Active Comparator: Residual pockets will be treated scaling and root planing
• laser + photosensitizer associated with scaling and root planing
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
Active Comparator: furcation defects will be treated by scaling and root planing

Locations

Country	Name	City	State
Brazil	School of dentistry - Paulista University UNIP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Paulista University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Clinical attachment level at 3 and 6 months.		baseline, 3 and 6 months post-therapies	Yes
Secondary	Probing Pocket depth		baseline, 3 and 6 months post-therapies.	Yes

External Links

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