Clinical trial NCT02627534: Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
Official title: Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Diabetes Mellitus
Keywords: Photodynamic therapy
Ultrasonic debridement
Chronic periodontitis
Type 2 diabetes
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.

Detailed description: Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.

Eligibility criteria: Inclusion Criteria:

* diagnosis of type 2 DM for ≥5 years
* DM treatment with oral hypoglycemic agents or insulin supplementation and diet
* glycated hemoglobin (HbA1c) levels from 6.5% to 11%
* at least 15 teeth (excluding third molars and teeth indicated for extraction)
* moderate to severe generalized chronic periodontitis (Armitage, 1999)
* agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).

Exclusion Criteria:

* medical conditions that required prophylactic antimicrobial coverage
* SRP in the previous 6 months
* antimicrobial therapies in the previous 6 months
* anti-inflammatory therapies in the previous 6 months
* systemic conditions, other than DM, that could affect the progression of chronic periodontitis
* current use of medication that could interfere with periodontal response to treatment
* pregnancy or lactation
* smoking

Primary outcomes:
measure: Probing Depth
timeFrame: Reductions in Probing Depth was compared at baseline and 180 days
Secondary outcomes:
measure: Clinical Attachment Level
timeFrame: Clinical Attachment Level gain was compared at baseline and 180 days
Other outcomes:
measure: Gingival Recession
timeFrame: Gingival Recession changes was compared at baseline and 180 days
Locations:
city: Sâo José dos Campos
country: Brazil
facility: Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
state: São Paulo
Study officials:
affiliation: ICT - UNESP
name: Mauro P Santamaria, PhD
role: STUDY_DIRECTOR
References:
citation: Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.