Evaluation of Periodontal Treatment in Patients With Bronchiectasis

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

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
    

Study Type

Interventional

Primary Outcome

Microbiological evaluation

Secondary Outcome

 Halitosis measurements

Condition

Bronchiectasis

Intervention

supragingival treatment

Study Arms / Comparison Groups

 G1-control group

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

90

Start Date

August 2015

Completion Date

December 2020

Primary Completion Date

July 2020

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.
      

Gender

All

Ages

35 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anna C Horliana, PhD, , 

Location Countries

Brazil

Location Countries

Brazil

NCT ID

NCT02514226

Organization ID

44769315.0.0000.5511

Responsible Party

Principal Investigator

Study Sponsor

University of Nove de Julho

Collaborators

 InCor Heart Institute

Study Sponsor

Anna C Horliana, PhD, Principal Investigator, University of Nove de Julho - UniNove

Verification Date

July 2018