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Evaluation of Periodontal Treatment in Patients With Bronchiectasis

Primary Purpose

Bronchiectasis, Periodontal Disease

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
supragingival treatment
periodontal treatment
periodontal treatment and photodynamic therapy
dental hygiene orientation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring microbiology, halitosis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • InCor Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

G1-control group

G2- positive control group

G3 -experimental active comparator group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Microbiological evaluation
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

Halitosis measurements
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.

Full Information

First Posted
July 22, 2015
Last Updated
June 27, 2023
Sponsor
University of Nove de Julho
Collaborators
InCor Heart Institute, University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02514226
Brief Title
Evaluation of Periodontal Treatment in Patients With Bronchiectasis
Official Title
Evaluation of Periodontal Treatment in Patients With Bronchiectasis: a Randomized, Single-center,One Year, Parallel Group, Non-inferiority Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
InCor Heart Institute, University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis, Periodontal Disease
Keywords
microbiology, halitosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G1-control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
G2- positive control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
G3 -experimental active comparator group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
supragingival treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
periodontal treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
periodontal treatment and photodynamic therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
dental hygiene orientation
Intervention Description
Plaque Control through the use of toothbrush and floss
Primary Outcome Measure Information:
Title
Microbiological evaluation
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Halitosis measurements
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna C Horliana, PhD
Organizational Affiliation
University of Nove de Julho - UniNove
Official's Role
Principal Investigator
Facility Information:
Facility Name
InCor Heart Institute
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28114928
Citation
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.
Results Reference
derived
PubMed Identifier
27084279
Citation
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.
Results Reference
derived

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Evaluation of Periodontal Treatment in Patients With Bronchiectasis

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