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| ID | Type | Description | Link |
|---|---|---|---|
| NTC02368678 | Registry Identifier | clinicaltrials.gov |
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The present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. Firs patients will be selected among those who participated in a privies study. Additional patients will be also invited. They must have gum disease and bad breath. Treatments will be completed within 24 hours and oral samples will be collected with thin paper points. Bad breath will be evaluated by a professional and a specific gas machine.
The present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy [(Full-mouth disinfection (FMD) combined with tongue scraping and antimicrobial photodynamic therapy (aPDT), and to assess its potential benefits for both periodontal and microbiological condition. A pilot study will be performed with participants who took part almost 10 years ago in the study NCT02368678. They will be invited by phone contact. In addition, new participants will be recruited by convenience in dental clinics from the Federal University of Minas Gerais until completion of 20 participants per group. Individuals with stage III periodontitis and halitosis (organoleptic method > 2), will be allocated into two periodontal treatment groups. Halitosis will be assessed using the organoleptic method and gas chromatography (OralChroma device) at three time points: before and after treatments. Microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. These samples will be analyzed by using real-time PCR (q-PCR) aiming at detecting target bacterial species.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-mouth scaling | Active Comparator | Full-mouth ultrasonic and manual periodontal instrumentation |
|
| Full-mouth scaling combined with antimicrobial photodynamic therapy | Experimental | Full-mouth ultrasonic and manual periodontal instrumentation combined with antimicrobial photodynamic therapy applied to tongue dorsum and periodontal pockets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-mouth scaling combined with antimicrobial photodynamic therapy | Radiation | After full-mouth scaling procedures antimicrobial photodynamic therapy was carried out using a laser-activated disinfection device with a red laser emission (wavelength: 630 nm, irradiance: 2000-4000 mW/cm², spot size at the probe tip: 8 mm diameter) and high-viscosity methylene blue gel (0.1 mg/mL) which was applied at six spots on the tongue dorsum. Antimicrobial photodynamic therapy was also applied iIn sites with altered periodontal pocket depth (≥ 4mm). The dye remained in the pockets for 10 minutes to ensure full absorption and its excess was rinsed with sterile saline after laser exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| sulfur volatile compounds changes | pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound | baseline versus 21 and 45 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in periodontal probing depth | Pre and pos-treatment changes in periodontal pocket depth (mm) | baseline versus 45 days after treatment |
| Changes in organoleptic testing | Pre and post-treatment changes in organoleptic scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando O Costa, doctorate | Federal University of Minas Gerais, Dental School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Minas Gerais, Dental School | Belo Horizonte | Minas Gerais | 31270-901 | Brazil |
Data will be analyzed by group and using numerical codes avoiding individual personal data identification. Data access will be protected by password.
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| full-mouth scaling | Procedure | Full-mouth scaling within 24 hours, divided into two sessions of ultrasonic instrumentation followed by manual supra- and subgingival scaling and root planing. Tongue cleaning was performed with a tongue scraper. |
|
| Baseline versus 45 days after treatment |
| Changes in tongue total bacteria count | Pre- and post-treatment changes in total bacteria counts from tongue dorsal samples | baseline versus 45 days after treatment |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |