NCT01595594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 16, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

August 15, 2011

Last Update Submit

July 15, 2014

Conditions

Periodontal DiseaseType 2 Diabetes

Keywords

Periodontal DiseasesType 2 Diabetes Mellitushemoglobin A1c protein

Outcome Measures

Primary Outcomes (1)

  • Clinical Attachment Level

    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.

    0, 1 month, 3 months and 6 months

Secondary Outcomes (1)

  • Microbial Load

    0, 3 months and 6 months

Study Arms (2)

Systemic Doxycycline

ACTIVE COMPARATOR
Drug: Systemic Doxycycline and Sham aPDT

aPDT+ Placebo

EXPERIMENTAL
Drug: aPDT + Doxycycline Placebo

Interventions

Systemic Doxycycline and Sham aPDTDRUG

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

Also known as: aPDT Sham
Systemic Doxycycline
aPDT + Doxycycline PlaceboDRUG

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

aPDT+ Placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Odontologia de Ribeirão Preto

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (3)

  • O'Connell PA, Taba M, Nomizo A, Foss Freitas MC, Suaid FA, Uyemura SA, Trevisan GL, Novaes AB, Souza SL, Palioto DB, Grisi MF. Effects of periodontal therapy on glycemic control and inflammatory markers. J Periodontol. 2008 May;79(5):774-83. doi: 10.1902/jop.2008.070250.

    PMID: 18454655RESULT

  • Lulic M, Leiggener Gorog I, Salvi GE, Ramseier CA, Mattheos N, Lang NP. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial. J Clin Periodontol. 2009 Aug;36(8):661-6. doi: 10.1111/j.1600-051X.2009.01432.x. Epub 2009 Jun 25.

    PMID: 19563331RESULT

  • Ramos UD, Ayub LG, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. Antimicrobial photodynamic therapy as an alternative to systemic antibiotics: results from a double-blind, randomized, placebo-controlled, clinical study on type 2 diabetics. J Clin Periodontol. 2016 Feb;43(2):147-55. doi: 10.1111/jcpe.12498. Epub 2016 Feb 19.

    PMID: 26710892DERIVED

MeSH Terms

Conditions

Periodontal DiseasesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman

Study Record Dates

First Submitted

August 15, 2011

First Posted

May 10, 2012

Study Start

March 1, 2010

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

July 16, 2014

Record last verified: 2014-07

Locations

BR(1)