Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Completed

Conditions: Diabetes Mellitus; Chronic Periodontitis

Treatments: Procedure: Ultrasonic debridement; Procedure: Antimicrobial photodynamic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02627534

NSFOSJC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Ultrasonic Debridement (UD)

Active Comparator group

Description:

Ultrasonic Debridement (UD) (n=20)

Treatment:

Procedure: Ultrasonic debridement

UD + Antimicrobial Photodynamic Therapy

Experimental group

Description:

Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)

Treatment:

Procedure: Antimicrobial photodynamic therapy

Procedure: Ultrasonic debridement