Evaluation of Periodontal Treatment in Patients With Bronchiectasis
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ClinicalTrials.gov Identifier: NCT02514226 |
Recruitment Status : Unknown
Verified July 2018 by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho.
Recruitment status was: Enrolling by invitation
First Posted : August 3, 2015
Last Update Posted : July 10, 2018
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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 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 |
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 |
- 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)
- 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.

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514226
Brazil | |
InCor Heart Institute | |
Sao Paulo, São Paulo, Brazil, 05403-900 |
Principal Investigator: | Anna C Horliana, PhD | University of Nove de Julho - UniNove |
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 |
Other Study ID Numbers: |
44769315.0.0000.5511 |
First Posted: | August 3, 2015 Key Record Dates |
Last Update Posted: | July 10, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
microbiology halitosis |
Periodontal Diseases Bronchiectasis Bronchial Diseases |
Respiratory Tract Diseases Mouth Diseases Stomatognathic Diseases |