Treatment of Chronic Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy

NCT02734784 | Completed Phase 4

• 1 other identifier: 14/09801-9
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic periodontitis (CP) is an infectious disease resulting in inflammation of the supporting structures of the teeth, progressive loss of bone loss and insertion. The aim of this study is to evaluate the effects of antimicrobial Photodynamic Therapy (aPDT) as adjuvant to periodontal surgery treatment (PST) in patients diagnosed with generalized severe chronic periodontitis (GSCP). Twenty patients with a clinical diagnosis of CP will be treated in a split-mouth design study to either aPDT associated with surgical access for scaling and root planning (SASRP) or SASRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in only one episodes. All patients will be monitored for 30 and 90 days after PST. Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the PST. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the PST) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Data obtained will be statistically analyzed.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in clinical attachment level at +120 days

  The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +120 days after the surgical periodontal therapy.

Secondary Outcomes (2)

• Change from baseline in counts of 40 subgingival bacterial species at +30 and +120 days

  Microbiological monitoring (at baseline and +30 and +120 days after the surgical periodontal therapy) using the checkerboard DNA-DNA hybridization

• Numbers of patients requiring additional periodontal treatment at +120 days.

  Considering each group separately, it will be evaluate the number of patients presenting at least a site with PPD≥5 mm and positiveBOP at 120 days post-therapy.

Study Arms (2)

Photodynamic Therapy and SRP

EXPERIMENTAL

Procedure: Photodynamic Therapy

SRP and Sham Photodynamic Therapy

SHAM COMPARATOR

Procedure: Sham Photodynamic Therapy

Interventions

Photodynamic Therapy PROCEDURE

After a surgical access, the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). Teeth with furcation lesion will increase over 60 seconds into the lesion. Before the application, the supragingival plaque will be removed.

Photodynamic Therapy and SRP

Sham Photodynamic Therapy PROCEDURE

After a surgical access, the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. Before the application, the supragingival plaque will be removed.

SRP and Sham Photodynamic Therapy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with \>35 years old
• A minimum of 15 teeth present
• One pair of posterior teeth in opposite sides with proximal sites showing probing depth and clinical attachment level ≥ 5 mm.

You may not qualify if:

• Positive history of antibiotic-therapy in the last six months
• Positive history of basic periodontal treatment in the last six months
• Systemic disease that can interfere with the progression of disease or response to treatment (eg, diabetes, immune disorders)
• Extensive prosthetic involvement
• Need for antibiotic prophylaxis for performing routine dental procedures
• Use of anti-inflammatory drugs for long periods of time
• Smoking
• Pregnancy

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (1)

• Martins SHL, Novaes AB Jr, Taba M Jr, Palioto DB, Messora MR, Reino DM, Souza SLS. Effect of surgical periodontal treatment associated to antimicrobial photodynamic therapy on chronic periodontitis: A randomized controlled clinical trial. J Clin Periodontol. 2017 Jul;44(7):717-728. doi: 10.1111/jcpe.12744. Epub 2017 Jun 29.

  PMID: 28498507 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Sérgio S. de Souza, Dr.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: February 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 12, 2016

Record last verified: 2016-04