PDT and Periodontal Treatment in DMT2 Patients

NCT01964833 | Completed

• 1 other identifier: 375.454
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontitis; Diabetes Mellitus Type 2

Keywords

clinical trial; DMT2; periodontitis; PDT

Outcome Measures

Primary Outcomes (1)

• Change in the clinical attachment level at 180 days.

  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.

  180 days

Secondary Outcomes (2)

• Changes in the fasting blood and glycated hemoglobin (HBA1C)

  Baseline, 15, 30, 90 and 180 days

• Cytokines in the crevicular fluid

  Baseline, 15, 30, 90 and 180 days

Study Arms (2)

Periodontal treatment

SHAM COMPARATOR

Conventional periodontal treatment with hygiene orientation, calculus removal and root scaling and planing. Sham PDT.

Procedure: Periodontal treatment

Periodontal Treatment and PDT

EXPERIMENTAL

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

Interventions

Periodontal treatment PROCEDURE

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.

Periodontal treatment

Periodontal treatment and PDT PROCEDURE

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.

Periodontal Treatment and PDT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Uncompensated diabetes, based on SBD criteria;
• Smoking habit in 12 months prior to treatment;
• Anemia;
• Active cancer;
• Current pregnancy;
• History of antibiotic therapy in previous six months;
• History of anti-inflammatory therapy in previous three months;
• Clotting disorder (use of anti-coagulant, presence of liver disease, thrombocytopenia and immunosuppression);
• Currently undergoing orthodontic treatment.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504015, Brazil

Location

Related Publications (1)

• Evangelista EE, Franca CM, Veni P, de Oliveira Silva T, Goncalves RM, de Carvalho VF, Deana AM, Fernandes KP, Mesquita-Ferrari RA, Camacho CP, Bussadori SK, Alvarenga LH, Prates RA. Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial. Trials. 2015 May 27;16:229. doi: 10.1186/s13063-015-0757-3.

  PMID: 26013003 DERIVED

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus, Type 2

Interventions

Periodontal Index; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Cristiane M Franca, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Post Graduation Program of Biophotonics applied to Health Sciences

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

BR (1)