PDT and Periodontal Treatment in DMT2 Patients (PDTDMT2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Nove de Julho
Sponsor:
Information provided by (Responsible Party):
Cristiane Miranda Franca, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT01964833
First received: October 10, 2013
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic control and increases proteins found in the acute phase of inflammation. The gold standard for the treatment of periodontal disease is oral hygiene orientation, scaling and planing. Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an antimicrobial technique and has demonstrated promising results. The aim of the proposed study is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the metabolic control of individuals with type 2 diabetes and the reduction of acute phase inflammatory markers. The patients will be randomized using a proper software program into two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by a specialist, followed by PT performed by two other healthcare professionals. At the end of each session, PDT (active or sham) will be administered by a fourth healthcare professional. The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW; exposure time = 90 seconds per point (9 J/point); and energy density = 22 J/cm2. The photosensitizer will be methylene blue (50 µg/mL). The patients will be re-evaluated 15, 30, 90 and 180 days after treatment. Serological exams with complete blood count, fasting glucose, glycated hemoglobin and crevicular fluid exams to screen for tumor necrosis factor alpha, interleukin 1, interleukin 6, osteocalcin, osteoprotegerin/RANKL will be performed at each evaluation. At baseline and 180 day periapical radiographs will be performed to evaluate the alveolar bone crest level. The data will be statistically evaluated using the most appropriate tests.


Condition Intervention
Periodontitis
Diabetes Mellitus Type 2
Procedure: Periodontal treatment
Procedure: Periodontal treatment and PDT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination of Photodynamic Therapy and Periodontal Treatment in Patients With Type 2 Diabetes Mellitus: Randomized, Double-blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Nove de Julho:

Primary Outcome Measures:
  • Change in the clinical attachment level at 180 days. [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Clinical attachment level is the depth measured from the CEJ (cement-enamel junction) to the bottom of the gingival sulcus. It indicates the amount of attachment that has been lost.


Secondary Outcome Measures:
  • Changes in the fasting blood and glycated hemoglobin (HBA1C) [ Time Frame: Baseline, 15, 30, 90 and 180 days ] [ Designated as safety issue: No ]
    These tests reflects the glycemic control at the moment of the dental exam and the average blood sugar level for the past two to three months.

  • Cytokines in the crevicular fluid [ Time Frame: Baseline, 15, 30, 90 and 180 days ] [ Designated as safety issue: No ]
    The crevicular fluid will be collected and investigated for the presence of IL-1, IL-6, TNF-alfa, osteocalcin, osteoprotegerin/RANKL in the crevicular fluid.


Estimated Enrollment: 44
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Periodontal treatment
Conventional periodontal treatment with hygiene orientation, calculus removal and root scaling and planing. Sham PDT.
Procedure: Periodontal treatment

Periodontal treatment will consist of oral hygiene instructions, with the monitored orientation of brushing technique and recommendation of the daily use of dental floss. Calculus deposits will also be removed using ultrasound equipment with the appropriate tips for periodontics as well as scaling and planing with dental instruments, as recommended by the AAP (2001). Treatment will be carried out in two to four one-hour sessions.

Patient will receive sham PDT.

Experimental: Periodontal Treatment and PDT
Conventional periodontal treatment with hygiene orientation, calculus removal, root scaling and planing. Active PDT with diode laser and methylene blue photosensitizer
Procedure: Periodontal treatment and PDT
Patients will receive periodontal treatment as previously described and PDT. PDT will be administered at the end of the periodontal treatment session at sites with pocket depths equal to or greater than 4 mm. A diode laser will be used at the 660 nm wavelength, P= 100 mW, 9 J/point, D = 22 J/cm2 (per point). The photosensitizer (BlueMet 0.005 % DMC)will be deposited at the fundus of the periodontal pocket using a syringe. The laser will be applied to the mucosa over the oral epithelium that lines the periodontal pocket using an optical fiber.

Detailed Description:

Randomization of the patients to the different groups will be performed with the appropriate software program. Only the lead researcher will have access to the randomization list. Allocation to the two groups will be carried out in blocks of four.

The patients will be sent to Operator A for the periodontal exam. Without knowledge of the results of this exam, the patients will be treated by Operators B and C for periodontal treatment, which will involve oral hygiene instructions as well as supra-gingival and sub-gingival scaling and planing in up to four sessions. At the end of each session, the patients will be sent to Operator D, who will administer either placebo or active PDT based on the content of the sealed envelope. Thus, both the patients and operator in charge of the periodontal exams will be blinded to the PDT protocol (double-blind study).

Fasting blood sugar and glycated hemoglobin exams will be performed at baseline as well as 15, 30, 90 and 180 days after the completion of treatment. All exams will be carried out at the same laboratory affiliated with the university.

The clinical periodontal exams will be performed by a single examiner specialized in periodontics, who will evaluate six regions of each tooth with a 15-mm probe (North Carolina model, Hu-Friedy, Chicago, IL, USA). The following aspects will be recorded: plaque index, bleeding upon probing, probing depth, gingival recession and attachment loss (Armitage, 2004). Evaluations will be carried out performed at baseline (prior to initial treatment) as well as 15, 30, 90 and 180 days after the completion of treatment.

Patients will receive periodontal treatment and photodynamic therapy (active or sham depending on the allocation).

Crevicular fluid will be collected from the previously defined sites with a probing depth equal to or greater than 4 mm that will receive treatment. Collection will be performed with relative isolation using cotton rolls following the removal of supra-gingival plaque with periodontal curettes and air drying for five seconds. Absorbent paper strips (PerioPaper, ProFlow Inc., Amityville, NY, USA) will be individually inserted into each site for 30 seconds (Rudin et al., 1970). The collections will be performed by a single researcher. The volume of crevicular fluid samples will be measured using the Periotron 8000 micro-moisture meter (Oraflow Inc., NY, USA). The samples will then be placed in duly identified sterile plastic microtubes, temporarily stored in dry ice and subsequently stored in a freezer at -80 ºC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Compensated type 2 diabetes mellitus or with adequate control based on the criteria of the Brazilian Society of Diabetes (SBD, 2012);
  2. Chronic periodontitis (AAP, 2001);
  3. Presence of at least 15 teeth and at least four teeth with bleeding upon probing and probing depth greater than 4 mm;
  4. Aged 18 years or older;
  5. Under follow up with an endocrinologist.

Exclusion Criteria:

  1. Uncompensated diabetes, based on SBD criteria;
  2. Smoking habit in 12 months prior to treatment;
  3. Anemia;
  4. Active cancer;
  5. Current pregnancy;
  6. History of antibiotic therapy in previous six months;
  7. History of anti-inflammatory therapy in previous three months;
  8. Clotting disorder (use of anti-coagulant, presence of liver disease, thrombocytopenia and immunosuppression);
  9. Currently undergoing orthodontic treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964833

Contacts
Contact: Cristiane M. Franca, PhD 55 11 9 8244 1343 cristiane321@gmail.com

Locations
Brazil
Universidade Nove de Julho Recruiting
São Paulo, SP, Brazil, 01504015
Contact: Cristiane M Franca, PhD    55 11 98244 1343    cristiane321@gmail.com   
Principal Investigator: Cristiane M Franca, PhD         
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Cristiane M Franca, PhD University of Nove de Julho
  More Information

No publications provided

Responsible Party: Cristiane Miranda Franca, Professor of the Post Graduation Program of Biophotonics applied to Health Sciences, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT01964833     History of Changes
Other Study ID Numbers: 375.454, 375.454
Study First Received: October 10, 2013
Last Updated: October 14, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Nove de Julho:
clinical trial
DMT2
periodontitis
PDT

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontitis
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 20, 2014