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Treatment of Aggressive Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy

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ClinicalTrials.gov Identifier: NCT02049008
Recruitment Status : Completed
First Posted : January 29, 2014
Last Update Posted : April 3, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Michel Reis Messora, University of Sao Paulo

Brief Summary:
The treatment of aggressive periodontitis (AgP) represents a challenge for clinicians, because there are no standardized protocols for efficient control of the disease. The aim of this study is to evaluate the effect of multiple applications of antimicrobial photodynamic therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in patients diagnosed with AgP. Twenty patients with a clinical diagnosis of AgP will be treated in a split-mouth design study to either aPDT associated with scaling and root planning (SRP) or SRP 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 four episodes (days 0, 2, 7 and 14). All patients will be monitored for 90 days. 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 nsPT. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at baseline and 14, 30 and 90 after the nsTP) for evaluation the volume of fluid (Periotron) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex). Data obtained will be statistically analyzed.

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Other: Photodynamic Therapy Other: 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: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical, Microbiological and Immunological Effects of Antimicrobial Photodynamic Therapy on Non-surgical Treatment of Aggressive Periodontitis: a Double-blind Split-mouth Randomized Controlled Clinical Trial.
Study Start Date : January 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Photodynamic Therapy Other: Photodynamic Therapy
After a full-mouth scaling and root planning (SRP), 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). The applications of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.

Sham Comparator: Sham Photodynamic Therapy Other: Sham Photodynamic Therapy
After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. The simulations of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.




Primary Outcome Measures :
  1. Change from Baseline in clinical attachment level at +90 days. [ Time Frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +90 days after the non-surgical periodontal therapy. ]

Secondary Outcome Measures :
  1. Change from baseline in counts of 40 subgingival bacterial species at +30 and +90 days [ Time Frame: Microbiological monitoring (at baseline and +30 and +90 days after the non-surgical periodontal therapy) using the checkerboard DNA-DNA hybridization ]
  2. Change from baseline in levels of IL-1β, IL-10 and TNF-alpha at +14 and +30 and +90 days [ Time Frame: Immunological monitoring (at baseline, +14 and +30 and +90 days after the non-surgical periodontal therapy) using Luminex. ]
  3. Numbers of patients requiring additional periodontal treatment at +90 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 90 days post-therapy. ]


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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects with <35 years old;
  • a minimum of 20 teeth present;
  • two pairs of single-rooted 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): NCT02049008


Locations
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Brazil
School of Dentistry of Ribeirao Preto - University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Michel R Messora, Dr. University of São Paulo - Ribeirão Preto

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Responsible Party: Michel Reis Messora, Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02049008     History of Changes
Other Study ID Numbers: 2012/13260-8 FAPESP
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Anti-Infective Agents
Anti-Bacterial Agents