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

Not Applicable

Completed

• Conditions: Chronic Periodontitis; Diabetes Mellitus
• Interventions: Procedure: Ultrasonic debridement; Procedure: Antimicrobial photodynamic therapy

• Registration Number: NCT02627534
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-10
• Study First Submitted: 2015-11-25
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-10
• Study First Posted: 2015-12-11
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UD + Antimicrobial Photodynamic Therapy	Antimicrobial photodynamic therapy	Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)
Ultrasonic Debridement (UD)	Ultrasonic debridement	Ultrasonic Debridement (UD) (n=20)
UD + Antimicrobial Photodynamic Therapy	Ultrasonic debridement	Ultrasonic Debridement + aPDT (UD+aPDT) (n=20)

Primary Outcome Measures

Name	Time	Method
Probing Depth	Reductions in Probing Depth was compared at baseline and 180 days	Assessed with manual probe (North Carolina, Hu-Friedy)

Secondary Outcome Measures

Name	Time	Method
Clinical Attachment Level	Clinical Attachment Level gain was compared at baseline and 180 days	Assessed with manual probe (North Carolina, Hu-Friedy)

Trial Locations

Locations (1)

Instituto de Ciência e Tecnologia de São José dos Campos - UNESP; 🇧🇷 Sâo José dos Campos, São Paulo, Brazil