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Treatment of Chronic Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy (TCPWRAAPT)

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ClinicalTrials.gov Identifier: NCT02734784
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Sergio Luis Scombatti de Souza, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Photodynamic Therapy Procedure: Sham Photodynamic Therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Microbiological of Antimicrobial Photodynamic Therapy on Surgical Treatment of Chronic Periodontitis: a Double-blind Split-mouth Randomized Controlled Clinical Trial.
Study Start Date : February 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Photodynamic Therapy and SRP Procedure: Photodynamic Therapy
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.

Sham Comparator: SRP and Sham Photodynamic Therapy Procedure: Sham Photodynamic Therapy
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.




Primary Outcome Measures :
  1. Change from Baseline in clinical attachment level at +120 days [ Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +120 days after the surgical periodontal therapy. ]

Secondary Outcome Measures :
  1. Change from baseline in counts of 40 subgingival bacterial species at +30 and +120 days [ Time Frame: Microbiological monitoring (at baseline and +30 and +120 days after the surgical periodontal therapy) using the checkerboard DNA-DNA hybridization ]
  2. Numbers of patients requiring additional periodontal treatment at +120 days. [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734784


Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Sérgio S. de Souza, Dr. University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sergio Luis Scombatti de Souza, Dr., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02734784     History of Changes
Other Study ID Numbers: 14/09801-9
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Anti-Bacterial Agents