Evaluation of Periodontal Treatment in Patients With Bronchiectasis

• ClinicalTrials.gov Identifier: NCT02514226
• Recruitment Status: Enrolling by invitation
• First Posted: August 3, 2015
• Last Update Posted: July 10, 2018
• Sponsor: University of Nove de Julho
• 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

Study Description

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 Design

• 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: July 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Brazil

InCor Heart Institute

Sao Paulo, São Paulo, Brazil, 05403-900

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Romero SS, Pinto EH, Longo PL, Dal Corso S, Lanza FC, Stelmach R, Rached SZ, Lino-Dos-Santos-Franco A, Mayer MP, Bussadori SK, Fernandes KP, Mesquita-Ferrari RA, Horliana AC. Effects of periodontal treatment on exacerbation frequency and lung function in patients with chronic periodontitis: study protocol of a 1-year randomized controlled trial. BMC Pulm Med. 2017 Jan 23;17(1):23. doi: 10.1186/s12890-016-0340-z. Erratum in: BMC Pulm Med. 2017 Mar 14;17 (1):51.

Pinto EH, Longo PL, de Camargo CC, Dal Corso S, Lanza Fde C, Stelmach R, Athanazio R, Fernandes KP, Mayer MP, Bussadori SK, Mesquita Ferrari RA, Horliana AC. Assessment of the quantity of microorganisms associated with bronchiectasis in saliva, sputum and nasal lavage after periodontal treatment: a study protocol of a randomised controlled trial. BMJ Open. 2016 Apr 15;6(4):e010564. doi: 10.1136/bmjopen-2015-010564.

• 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
• Last Update Posted: July 10, 2018
• Last Verified: July 2018

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:

Periodontal Diseases; Bronchiectasis; Bronchial Diseases; Respiratory Tract Diseases; Mouth Diseases; Stomatognathic Diseases; Methylene Blue; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action