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Evaluation of Periodontal Treatment in Patients With Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02514226
Recruitment Status : Recruiting
First Posted : August 3, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
InCor Heart Institute
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP #2015/20535-1)
Information provided by (Responsible Party):
Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

Brief Summary:
Background: Association between periodontal disease (PD) and chronic obstructive pulmonary disease (COPD) has been widely studied and the aspiration of periodontal pathogens is one of the most accepted causal mechanisms for pulmonary exacerbation. Bronchiectasis is clinically quite similar with COPD, including chronic administration of antibiotics, increased systemic inflammation and relatively similar clinical symptoms, but for the time being; there are no studies that have correlated this condition to PD. This study will evaluate if the scaling and root planning (SRP) associated with photodynamic therapy improves periodontal clinical parameters, halitosis, and the quantity of microorganisms associated with exacerbation of bronchiectasis in saliva, subgingival periodontal microenvironment, sputum and nasal lavage at baseline, after 3 months and one year of SRP. Methods/Design: Ninety patients with chronic periodontal disease and bronchiectasis will be enrolled in the study and they will be treated as follow:G1 control (n = 30) - supragingival scaling (SS) and dental hygiene orientation (DHO); G2 experimental (n = 30) - SRP + DHO; G3- experimental (n = 30) - SRP + PDT + DHO. The quantification of bacterial groups commonly associated with exacerbation of bronchiectasis (P aeruginosa, S. aureus) and periodontal diseases (P. gingivalis), will be evaluated in periodontal pockets, saliva, nasal lavage and sputum by quantitative PCR at baseline 3 months and one year after the SRP. G1 patients will receive SRP upon completion of the investigation. If the mean depth of probing of this group worsen (> 1mm) at 3 months they will be excluded from the study, treated (SRP) and the data will be described. Discussion: The results of this protocol will determine the efficacy of periodontal treatment in decreasing the total amount microorganisms in saliva periodontal pocket, sputum and nasal lavage, the most probable niches of bronchiectasis exacerbation, and reducing local inflammation and halitosis after 3 months and one year. It is expected an higher improvement in all parameters measured over 3 months and 1 year for G3

Condition or disease Intervention/treatment Phase
Bronchiectasis Periodontal Disease Procedure: supragingival treatment Procedure: periodontal treatment Procedure: periodontal treatment and photodynamic therapy Other: dental hygiene orientation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Periodontal Treatment in Patients With Bronchiectasis: a Randomized, Single-center,One Year, Parallel Group, Non-inferiority Clinical Study
Study Start Date : August 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath

Arm Intervention/treatment
Placebo Comparator: G1-control group

Arm description: G1 - control group - (n = 30) dental hygiene orientation (DHO) + supragingival treatment + simulation of using photodynamic therapy (PDT).

In G1, all participants will receive supragingival treatments by an experienced specialist with universal curettes and ultrasound. Supragingival treatment will be performed above the gingival margin. The simulation of using photodynamic therapy (PDT) will be performed with laser turned off. No antibiotics and oral antiseptics will be prescribed.

Procedure: supragingival treatment
In G1, all participants will receive supragingival treatments by an experienced specialist with universal curettes (Hu-Friedy) and ultrasound (Ultra Sound Dabi Atlante - Profi Neo US, Ribeirao Preto, Brazil). Supragingival treatment will be performed above the gingival margin.

Other: dental hygiene orientation
Plaque Control through the use of toothbrush and floss

Active Comparator: G2- positive control group

Arm description: G2 - positive control group (gold standard) - (n = 30) - DHO + periodontal treatment + simulation of using PDT.

All participants will receive periodontal treatment - scaling and root planning (SRP) by an experienced specialist with universal curetes and ultrasound in a full mouth manner. The simulation of using photodynamic therapy (PDT) will be performed with laser turned off. No antibiotics and oral antiseptics will be prescribed

Procedure: periodontal treatment
All participants receive periodontal treatments by an experienced specialist with universal curettes (Hu-Friedy) and ultrasound (Ultra Sound Dabi Atlante - Profi Neo US, Ribeirao Preto, Brazil) in a full mouth manner.

Other: dental hygiene orientation
Plaque Control through the use of toothbrush and floss

Active Comparator: G3 -experimental active comparator group

Arm description: G3 - experimental group - (n = 30) DHO +SRP + PDT with methylene blue

In G3, periodontal treatment and photodynamic therapy (PDT) will be performed. The scaling and root planing will be performed identical as G2. The PDT will be administered in periodontal pockets > 4mm. Methylene blue will be applied in the deep of periodontal pockets. After 5 minutes of application the red laser diode (λ = 660 nm) will be applied with output power of 100 mW with 90 seconds of exposure, i.e. 9J in each point. Applications will be held in six sites around the tooth in all teeth. To finalize, 1 minute of irradiation in scan around each tooth and rinsing with saline solution to remove the photosensitizer

Procedure: periodontal treatment and photodynamic therapy
In G3, the periodontal treatment will be performed identical as G2. PDT will be administered in periodontal pockets > 4mm. Methylene blue will be applied in the deep of periodontal pockets. After 5 minutes of application the red laser diode (λ = 660 nm) will be applied with output power of 100 mW (Therapy XT, DMC, São Carlos, Brazil) with 90 seconds of exposure, i.e. 9J in each point. Applications will be held in six sites around the tooth in all teeth. To finalize, 1 minute of irradiation in scan around each tooth and rinsing with saline solution to remove the FS.

Other: dental hygiene orientation
Plaque Control through the use of toothbrush and floss




Primary Outcome Measures :
  1. Microbiological evaluation [ Time Frame: 3 months ]
    Samples will be defrosted and vortexed. DNA extraction will be performed according to manufacturer's instructions. Quantitative PCR of total amount of Bacteria, Archeae, periodontopathogens and Gama-Proteobacteria and Firmicutes groups will be performed with Real-time polymerase chain reaction (PCR)


Secondary Outcome Measures :
  1. Halitosis measurements [ Time Frame: 3 months ]
    The air inside the oral cavity will be collected with a syringe and injected into oral ChromaTM, a portable device connected to the computer with captures graph peaks of gas concentration values.



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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:

  • Patients must have > 35 years, both genders, > 10 teeth with chronic moderate generalized periodontal disease , i.e. more than 30% of teeth examined with ≥ 4 mm probing depth.

Exclusion Criteria:

  • Exclusion criteria include smokers or former smokers for less than five years, pregnant, people with cystic fibrosis and asthma, phenytoin or cyclosporine users (because they affect periodontal status), decompensated systemic diseases requiring prophylactic antibiotic therapy for periodontal treatment, who used oral antiseptics or anti-inflammatory in the last 3 months, or periodontal treatment performed in the last 6 months.

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): NCT02514226


Contacts
Contact: Anna C Horliana, PhD +55 13 997419993 annacrth@gmail.com
Contact: Priscila L Longo, PhD +55 11 30917348 pllongo@gmail.com

Locations
Brazil
InCor Heart Institute Recruiting
Sao Paulo, São Paulo, Brazil, 05403-900
Contact: Rafael Stelmach, PhD    +55 11 2661-5413    rafael.stelmach@incor.usp.br   
Contact: Anna Carolina Horliana, PhD    +55 13 981999848    annacrth@gmail.com   
Sponsors and Collaborators
University of Nove de Julho
InCor Heart Institute
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP #2015/20535-1)
Investigators
Principal Investigator: Anna C Horliana, PhD University of Nove de Julho - UniNove

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Carolina Ratto Tempestini Horliana, Professor of postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02514226     History of Changes
Other Study ID Numbers: 44769315.0.0000.5511
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho:
microbiology
halitosis

Additional relevant MeSH terms:
Bronchiectasis
Periodontal Diseases
Gingival Diseases
Bronchial Diseases
Respiratory Tract Diseases
Mouth Diseases
Stomatognathic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action