Evaluation of Periodontal Treatment in Patients With Bronchiectasis

NCT02514226 | Unknown DMC

• 1 other identifier: 44769315.0.0000.5511
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchiectasis; Periodontal Disease

Keywords

microbiology; halitosis

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Secondary Outcomes (1)

• Halitosis measurements

  3 months

Study Arms (3)

G1-control group

PLACEBO COMPARATOR

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; Other: dental hygiene orientation

G2- positive control group

ACTIVE COMPARATOR

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; Other: dental hygiene orientation

G3 -experimental active comparator group

ACTIVE COMPARATOR

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; Other: dental hygiene orientation

Interventions

supragingival treatment PROCEDURE

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.

G1-control group

periodontal treatment PROCEDURE

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.

G2- positive control group

periodontal treatment and photodynamic therapy PROCEDURE

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.

G3 -experimental active comparator group

dental hygiene orientation OTHER

Plaque Control through the use of toothbrush and floss

G1-control group; G2- positive control group; G3 -experimental active comparator group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• InCor Heart Institute: collaborator
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

InCor Heart Institute

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 28114928 DERIVED

• 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.

  PMID: 27084279 DERIVED

MeSH Terms

Conditions

Bronchiectasis; Periodontal Diseases; Halitosis

Interventions

Periodontal Index; Photochemotherapy

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Anna C Horliana, PhD

  University of Nove de Julho - UniNove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of postgraduate program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, UNINOVE, São Paulo, Brazil

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: August 3, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Locations

BR (1)