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

NCT ID: NCT01595594

Last Updated: 2014-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Systemic Doxycycline

Group Type ACTIVE_COMPARATOR

Systemic Doxycycline and Sham aPDT

Intervention Type DRUG

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

aPDT+ Placebo

Group Type EXPERIMENTAL

aPDT + Doxycycline Placebo

Intervention Type DRUG

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

Interventions

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Systemic Doxycycline and Sham aPDT

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

Intervention Type DRUG

aPDT + Doxycycline Placebo

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

Intervention Type DRUG

Other Intervention Names

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aPDT Sham

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Arthur Belem Novaes Jr

Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculdade de Odontologia de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 18454655 (View on PubMed)

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.

Reference Type RESULT
PMID: 19563331 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26710892 (View on PubMed)

Other Identifiers

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FAPESP

Identifier Type: -

Identifier Source: org_study_id

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