Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus

NCT07463859 — Not applicable, Recruiting, 32 participants, University of Sao Paulo

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Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial

Registry	NCT07463859
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	32 (Estimated)
Sponsor	University of Sao Paulo (Other)
Conditions	Type 2 Diabetes, Halitosis, Periodontitis
Interventions	Scaling and root planing, Photodynamic Therapy with Conventional Methylene Blue (Procedure)
Dates	start 2026-04-02 (estimated), primary completion 2027-01-31 (estimated), completion 2027-02-28 (estimated), first posted 2026-03-11, last updated 2026-03-16
Locations	1 site in Brazil

-Summary

The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.

* Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.
* After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.

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+Arms and interventions

Arm	Type	Interventions	Description
aPDT - antimicrobial photodynamic therapy	Experimental	Procedure: Photodynamic Therapy with Conventional Methylene Blue	Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.
Control	Active comparator	Procedure: Scaling and root planing	Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper

Scaling and root planing (Procedure): Mechanical removal of biofilm in periodontal pockets and tongue
Photodynamic Therapy with Conventional Methylene Blue (Procedure): Antimicrobial photodynamic therapy in periodontal pockets and tongue

+Outcome measures

Primary outcomes

Halitosis [From enrollment to the end of treatment at 6 months]: Measurement of oral volatile compounds by gas chromatography

Secondary outcomes

Probing depth [From enrollment to the end of treatment at 6 months]: Measurement in milimeters of the periodontal pocket
Clinical Attachment level [From enrollment to the end of treatment at 6 months]: Measuremet in milimeters from cementoenamel junction to bottom of the pocket

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria
* Stage 3 or 4 periodontitis
* No periodontal treatment in the previous 12 months
* a minimum of 20 remaining teeth.

Exclusion Criteria:

* Smokers
* Alcohol-dependent individuals
* Pregnant or lactating women
* Patients with renal disorders
* Patients using medications that affect the periodontium

+Locations (1)

Facility	City	Country	Status
Bauru School of Dentistry	Bauru, São Paulo	Brazil	Recruiting

+Publications

Bruno LH, Mandetta ARH, Sobral APT, Leal Goncalves ML, Santos EM, Fossati AL, Gallo JMAS, Motta PB, Deana AM, Horliana ACRT, Motta LJ, Ferrari RAM, Santos Fernandes KP, Kalil Bussadori S. Assessment of photodynamic therapy with annatto and led for the treatment of halitosis in mouth-breathing children: Randomized controlled clinical trial. PLoS One. 2024 Sep 3;19(9):e0307957. doi: 10.1371/journal.pone.0307957. eCollection 2024. PMID 39226284
da Mota ACC, Goncalves MLL, Horliana ACRT, Deana AM, de Souza Cavalcante LA, Gomes AO, Mayer MPA, Suguimoto ESA, Fernandes KPS, Mesquita-Ferrari RA, Prates RA, Motta LJ, Bussadori SK. Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial. Lasers Med Sci. 2022 Mar;37(2):877-886. doi: 10.1007/s10103-021-03325-x. Epub 2021 May 13. PMID 33987732