Evaluation of Periodontal Treatment in Patients With Bronchiectasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

NCT03643302

Bronchiectasis Adult

COMPLETED

Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis

NCT02731482

Bronchiectasis

COMPLETED NA

Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

NCT02823587

Bronchiectasis

UNKNOWN NA

Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

NCT06393257

Bronchiectasis Adult

RECRUITING NA

Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis

NCT02048397

Bronchiectasis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiectasis Periodontal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

supragingival treatment

Intervention Type 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.

dental hygiene orientation

Intervention Type OTHER

Plaque Control through the use of toothbrush and floss

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

Group Type ACTIVE_COMPARATOR

periodontal treatment

Intervention Type 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.

dental hygiene orientation

Intervention Type OTHER

Plaque Control through the use of toothbrush and floss

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

Group Type ACTIVE_COMPARATOR

periodontal treatment and photodynamic therapy

Intervention Type 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.

dental hygiene orientation

Intervention Type OTHER

Plaque Control through the use of toothbrush and floss

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

dental hygiene orientation

Plaque Control through the use of toothbrush and floss

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No