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

NCT01670305 | Completed DMC

• 1 other identifier: 0272.0.251.000-10
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease

Outcome Measures

Primary Outcomes (1)

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

  baseline, 3 and 6 months post-therapies

Secondary Outcomes (1)

• Probing Pocket depth

  baseline, 3 and 6 months post-therapies.

Study Arms (5)

Residual pocket - PDT

EXPERIMENTAL

Photosensitizer plus diiodo laser

Procedure: Residual pockets will be treated by laser + photosensitizer

Residual pocket - Photosensitizer

PLACEBO COMPARATOR

Photosensitizer alone

Procedure: Residual pockets will be treated only photosensitizer

Residual pocket - SRP

ACTIVE COMPARATOR

scaling and root planing alone

Procedure: Residual pockets will be treated scaling and root planing

Furcation - PDT+SRP

EXPERIMENTAL

Photosensitizer plus diiodo laser associated with scaling and root planing

Procedure: laser + photosensitizer associated with scaling and root planing

Furcation - SRP

ACTIVE COMPARATOR

Photosensitizer associated with scaling and root planing

Procedure: furcation defects will be treated by scaling and root planing

Interventions

Residual pockets will be treated by laser + photosensitizer PROCEDURE

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

Residual pocket - PDT

Residual pockets will be treated only photosensitizer PROCEDURE

Placebo Comparator: Residual pockets will be treated only photosensitizer

Residual pocket - Photosensitizer

Residual pockets will be treated scaling and root planing PROCEDURE

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

Residual pocket - SRP

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 - PDT+SRP

furcation defects will be treated by scaling and root planing PROCEDURE

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

Furcation - SRP

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Paulista University: lead

Study Sites (1)

School of dentistry - Paulista University UNIP

São Paulo, São Paulo, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Photosensitizing Agents; Root Planing; Lasers; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Radiation-Sensitizing Agents; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: August 22, 2012
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: March 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

BR (1)