Clinical trial NCT01595594: Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
Official title: Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontal Disease
Type 2 Diabetes
Keywords: Periodontal Diseases
Type 2 Diabetes Mellitus
hemoglobin A1c protein
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2012-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will be selected and divided in two groups. On the treatment stage, the control group (Group C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The investigators expect to find identical or better results for the test group.


Eligibility criteria: Inclusion Criteria:

* Poorly Controlled Type 2 Diabetes (HbA1c \> 7%)
* Advanced Chronic Periodontitis
* Presence of 15 teeth

Exclusion Criteria:

* Use on antiinflammatory drugs
* Use of antibiotics less then 6 months before therapy
* Smokers
* Positive for HIV
* Periodontal treatment less then 6 months before therapy
* Advanced complications of Diabetes

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 0, 1 month, 3 months and 6 months
Secondary outcomes:
measure: Microbial Load
timeFrame: 0, 3 months and 6 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Faculdade de Odontologia de Ribeirão Preto
state: São Paulo
Study officials:
References:
citation: O'Connell PA, Taba M, Nomizo A, Foss Freitas MC, Suaid FA, Uyemura SA, Trevisan GL, Novaes AB, Souza SL, Palioto DB, Grisi MF. Effects of periodontal therapy on glycemic control and inflammatory markers. J Periodontol. 2008 May;79(5):774-83. doi: 10.1902/jop.2008.070250.
citation: Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.
citation: Ramos UD, Ayub LG, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. Antimicrobial photodynamic therapy as an alternative to systemic antibiotics: results from a double-blind, randomized, placebo-controlled, clinical study on type 2 diabetics. J Clin Periodontol. 2016 Feb;43(2):147-55. doi: 10.1111/jcpe.12498. Epub 2016 Feb 19.