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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02627534
Other study ID # NSFOSJC
Secondary ID
Status Completed
Phase N/A
First received November 25, 2015
Last updated December 10, 2015
Start date April 2014
Est. completion date October 2015

Study information

Verified date December 2015
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasonic debridement
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
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.

Locations

Country Name City State
Brazil Instituto de Ciência e Tecnologia de São José dos Campos - UNESP Sâo José dos Campos São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Gingival Recession Assessed with manual probe (North Carolina, Hu-Friedy) Gingival Recession changes was compared at baseline and 180 days No
Primary Probing Depth Assessed with manual probe (North Carolina, Hu-Friedy) Reductions in Probing Depth was compared at baseline and 180 days No
Secondary Clinical Attachment Level Assessed with manual probe (North Carolina, Hu-Friedy) Clinical Attachment Level gain was compared at baseline and 180 days No
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