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

Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02627534
Enrollment
20
Registered
2015-12-11
Start date
2014-04-30
Completion date
2015-10-31
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis, Diabetes Mellitus

Keywords

Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes

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.

Interventions

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.

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.

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Probing DepthReductions in Probing Depth was compared at baseline and 180 daysAssessed with manual probe (North Carolina, Hu-Friedy)

Secondary

MeasureTime frameDescription
Clinical Attachment LevelClinical Attachment Level gain was compared at baseline and 180 daysAssessed with manual probe (North Carolina, Hu-Friedy)

Other

MeasureTime frameDescription
Gingival RecessionGingival Recession changes was compared at baseline and 180 daysAssessed with manual probe (North Carolina, Hu-Friedy)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026