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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627534
• Other study ID #: NSFOSJC
• 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

• Chronic Periodontitis
• Diabetes Mellitus
• Periodontitis

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