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Photodynamic therapy with toluidine blue (t-bu) in the treatment of periodontitis in type 2 diabetic patients

Effect of aPDT mediate by Toluidine Blue (t-Bu) on the periodontal treatment of residual pockets in diabetes mellitus patient: a randomized clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4yhwvvc
Enrollment
Unknown
Registered
2023-12-06
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Interventions

Double blind study that will include forty-two patients with periodontitis, presenting a medical diagnosis of uncompensated type 2 diabetes mellitus (HbA1c = 7.0%) and who are undergoing periodontal m
SRP+aPDT group (n=21) - SRP in a single session and irrigation of the pockets with 0.5 ml of toluidine blue (t-Bu) solution (0.5 mg/mL) followed by irradiation with a diode laser Aluminum Gallium Indi
660 ± 10 nm) after 60 seconds right after SRP and 7 days after treatment
E02.186.500
E06.721.189.350

Sponsors

Universidade Estadual Paulista (Unesp), Faculdade de Odontologia, Araçatuba
Lead Sponsor
Universidade Estadual Paulista (Unesp), Faculdade de Odontologia, Araçatuba
Collaborator

Eligibility

Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged = 30 and = 70 years; diagnosis of periodontitis according to the new classification with interproximal clinical attachment level (CAL) = 2 or CIN = 3 mm in more than 2 non-adjacent teeth (excluding the CAL limits cited in cases related to periodontitis: gingival recession of traumatic origin; caries; teeth extending into the cervical area of ??the teeth; presence of CAL distally to the second molar and associated with poor dental position or extraction of the third molar; endodontic lesion reaching the gingival margin and occurrence of vertical root fracture); who have undergone periodontal treatment within a maximum period of 3 months with at least 4 sites with PD =4mm with BOP; patients diagnosed with type 2 diabetes mellitus (HbA1c = 7.0%); have at least 15 teeth, excluding third molars

Exclusion criteria

Exclusion criteria: Smokers or ex-smokers for more than 5 years; patients with anemia; patient with active cancer and history of chemotherapy; antibiotic therapy within the previous 6 months; hx of anti-inflammatory therapy in the past 6 months; patient with blood disorders; pregnancy; patient undergoing orthodontic treatment, patients requiring prophylactic antibiotic therapy

Design outcomes

Primary

MeasureTime frame
Clinical attachment gain 6 months after treatment, verified by periodontal probing, to verify a variation of 1mm of clinical periodontal attachment before and after the intervention

Secondary

MeasureTime frame
Variation in the values ??of the laboratory test for glycated hemoglobin at 180 days after treatment, verified through laboratory analysis with the percentage rate, to verify the percentage variation in the levels of circulating glycated hemoglobin in the blood before and after the intervention

Countries

Brazil

Contacts

Public ContactLeticia Theodoro

Faculdade de Odontologia de Araçatuba - FOA/UNESP

leticia.theodoro@unesp.br+55-18-36362860

Outcome results

None listed

Source: REBEC (via WHO ICTRP)