Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics

Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01595594

Enrollment

Registered

2012-05-10

Start date

2010-03-31

Completion date

2012-10-31

Last updated

2014-07-16

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

Conditions

Periodontal Disease, Type 2 Diabetes

Keywords

Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein

Brief summary

The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will be selected and divided in two groups. On the treatment stage, the control group (Group C) will receive standard non surgical periodontal treatment. The Test Group (Group T) will be treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish 3 months. The follow-up will be done for 6 months. The clinical parameters measured will be: plaque index, pocket depth, bleeding on probing, relative clinical insertion level and suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1, TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The investigators expect to find identical or better results for the test group.

Interventions

DRUGSystemic Doxycycline and Sham aPDT

It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days

DRUGaPDT + Doxycycline Placebo

The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Poorly Controlled Type 2 Diabetes (HbA1c \> 7%) * Advanced Chronic Periodontitis * Presence of 15 teeth

Exclusion criteria

* Use on antiinflammatory drugs * Use of antibiotics less then 6 months before therapy * Smokers * Positive for HIV * Periodontal treatment less then 6 months before therapy * Advanced complications of Diabetes

Design outcomes

Primary

Measure	Time frame	Description
Clinical Attachment Level	0, 1 month, 3 months and 6 months	There will be analyzed the changes in clinical attachment level at the proposed experimental times. Clinical attatchment level is known as a proper outcome to evaluate periodontal disease progression or regression. It is measured as the distace between the deepet point fo the periodontal pocket and a stabilshed point, on the case of this study, the tooth occlusal surface.

Secondary

Measure	Time frame	Description
Microbial Load	0, 3 months and 6 months	There will be mesaured the changes of microbial load at the proposed experimental times. Microbial load at deep pocket seems to change regarding periodontal treatment and it is expected a reduction after treatment. measuring on various experimental times it will be possible to evaluate treatment stability on reducing periodontopathogens.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026