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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Type 2 Diabetes; Halitosis
• Intervention / Treatment: Procedure: Photodynamic Therapy with Conventional Methylene Blue; Procedure: Scaling and root planing

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla A. Damante, PhD; Phone Number: +551432266064; Email: cdamante@usp.br

Study Locations

• Brazil
  • São Paulo
    • Bauru, São Paulo, Brazil, 17012901
      • Recruiting
      • Bauru School of Dentistry
      • Contact: Carla A. Damante, PhD; Phone Number: +55 1432266064; Email: cdamante@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aPDT - antimicrobial photodynamic therapy; Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.	Procedure: Photodynamic Therapy with Conventional Methylene Blue; Antimicrobial photodynamic therapy in periodontal pockets and tongue
Active Comparator: Control; Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper	Procedure: Scaling and root planing; Mechanical removal of biofilm in periodontal pockets and tongue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Halitosis	Measurement of oral volatile compounds by gas chromatography	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	Measurement in milimeters of the periodontal pocket	From enrollment to the end of treatment at 6 months
Clinical Attachment level	Measuremet in milimeters from cementoenamel junction to bottom of the pocket	From enrollment to the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Bruno LH,Mandetta ARH,Sobral APT,Leal Gonçalves ML,Santos EM,Fossati AL,Gallo JMAS,Motta PB,Deana AM,Horliana ACRT,Motta LJ,Ferrari RAM,Santos Fernandes KP,Kalil Bussadori S
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Photodynamic Therapy; periodontitis; Halitosis; lasers
• Additional Relevant MeSH Terms: Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Metabolic Diseases; Signs and Symptoms, Digestive; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Periodontitis; Diabetes Mellitus, Type 2; Halitosis; Therapeutics; Drug Therapy; Digestive System and Oral Physiological Phenomena; Combined Modality Therapy; Phototherapy; Dentistry; Dental Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Subgingival Curettage; Preventive Dentistry; Photochemotherapy; Root Planing; Tooth Exfoliation
• Other Study ID Numbers: 7.885.095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No