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Chronic PeriodontitisPhase 4NCT01034501

Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

A Phase 4 study testing photodynamic therapy in people with Chronic Periodontitis, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
photodynamic therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteBrazil
Study dates
Feb 2010to Sep 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic Periodontitis (Tonetti, Claffey, 2005)
  • 10 or more teeth
  • 2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation

Who cannot join

  • Profilatic antibiotics
  • Diabetes, immunosuppression, pregnancy nursing mother
  • Smoking
  • Medication that might interfere with periodontal healing
  • Previous periodontal treatment or antibiotics (6 months)
  • Experimental teeth with mobility II or III, or endodontic problem

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Faculdade de Odontologia da Universidade de São Paulo (FOUSP)

    São Paulo, São Paulo, 05508-000

Other trials in Brazil

About this study

Official title: Efficacy of Adjunctive Photodynamic Therapy in Non-surgical Treatment of Chronic Periodontitis: a Randomized , Controlled Clinical Trial

The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham

Read the detailed description

The goal of periodontal treatment is to restore tissue health through the elimination and control of etiologic factors, reducing the microbial aggression. Some microorganisms persist in the root surface even after scraping. Thus, the conventional mechanical treatment may fail to reduce the number of periodontal pathogens to levels compatible with health. This study will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis.

Being tested
sham procedure, photodynamic therapy
Keywords
periodontitis, photodynamic therapy
Medical subject headings
Chronic Periodontitis, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sham procedureDevice

    Also called Laser Hand - MM Optics (ANVISA: 80051420009)

    non activated laser tip

  • photodynamic therapyDevice

    Also called Laser Hand - MM Optics (ANVISA: 80051420009)

    photodynamic therapy 660 nm,40 mW,60 Hz

Study groups in NCT01034501
Study groupRoleWhat they receive
photodynamic therapyActive comparatorphotodynamic therapy 660 nm,40 mW,60 Hz
Receives: Device: photodynamic therapy
sham procedureSham comparatorNot activation of laser device
Receives: Device: sham procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in mean attachment level

    Measured: 12 months

Secondary outcomes (3)

  1. Change in probing pocket depth

    Measured: 12 months

  2. Change in periodontal pathogens(Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans)counts.

    Measured: 12 months

  3. Change in fluid inflammatory markers (Il-1B, Il-6, Il-8, PGE2, TNF-a, Il-10, MMP-2, TIMP-1, MMP-8)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01034501
Sponsor's protocol ID
CEP2112008
Status last verified
Oct 2013
First submitted
16 Dec 2009
Last updated
10 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Christodoulides N, Nikolidakis D, Chondros P, Becker J, Schwarz F, Rossler R, Sculean A. Photodynamic therapy as an adjunct to non-surgical periodontal treatment: a randomized, controlled clinical trial. J Periodontol. 2008 Sep;79(9):1638-44. doi: 10.1902/jop.2008.070652.

    PubMed 18771363

  • Braun A, Dehn C, Krause F, Jepsen S. Short-term clinical effects of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial. J Clin Periodontol. 2008 Oct;35(10):877-84. doi: 10.1111/j.1600-051X.2008.01303.x. Epub 2008 Aug 17.

    PubMed 18713259

  • Carvalho VF, Andrade PV, Rodrigues MF, Hirata MH, Hirata RD, Pannuti CM, De Micheli G, Conde MC. Antimicrobial photodynamic effect to treat residual pockets in periodontal patients: a randomized controlled clinical trial. J Clin Periodontol. 2015 May;42(5):440-7. doi: 10.1111/jcpe.12393. Epub 2015 Apr 22.

    PubMed 25808980

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing photodynamic therapy in people with Chronic Periodontitis, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean attachment level (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01034501, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2013.

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