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

NCT07463859 | Recruiting

• 1 other identifier: 7.885.095
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Halitosis; Periodontitis

Keywords

Halitosis; periodontitis; lasers; Photodynamic Therapy

Outcome Measures

Primary Outcomes (1)

• Halitosis

  Measurement of oral volatile compounds by gas chromatography

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• Probing depth

  From enrollment to the end of treatment at 6 months

• Clinical Attachment level

  From enrollment to the end of treatment at 6 months

Study Arms (2)

aPDT - antimicrobial photodynamic therapy

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper

Procedure: Scaling and root planing

Interventions

Scaling and root planing PROCEDURE

Mechanical removal of biofilm in periodontal pockets and tongue

Control

Photodynamic Therapy with Conventional Methylene Blue PROCEDURE

Antimicrobial photodynamic therapy in periodontal pockets and tongue

aPDT - antimicrobial photodynamic therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012901, Brazil

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Halitosis; Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Photochemotherapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Central Study Contacts

Carla A. Damante, PhD

CONTACT

+551432266064; cdamante@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Simulation of laser treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor - Principal investigator

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

BR (1)