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NCT Number: NCT02627534

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ciência e Tecnologia de São José dos Campos - UNESP

Sâo José Dos Campos, São Paulo, 12245-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonic debridement

Procedure

All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.

antimicrobial photodynamic therapy

Procedure

After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.

Primary outcomes

  1. Probing Depth

    Time frame: Reductions in Probing Depth was compared at baseline and 180 days

    Assessed with manual probe (North Carolina, Hu-Friedy)

Secondary outcomes

  1. Clinical Attachment Level

    Time frame: Clinical Attachment Level gain was compared at baseline and 180 days

    Assessed with manual probe (North Carolina, Hu-Friedy)

Other outcomes

  1. Gingival Recession

    Time frame: Gingival Recession changes was compared at baseline and 180 days

    Assessed with manual probe (North Carolina, Hu-Friedy)

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2015
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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