Periodontal DiseasePhase 3NCT01595594
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
A Phase 3 study of Periodontal Disease and Type 2 Diabetes, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Periodontal Disease, Type 2 Diabetes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Oct 2012
- Phase
- Phase 3
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poorly Controlled Type 2 Diabetes (HbA1c > 7%)
- Advanced Chronic Periodontitis
- Presence of 15 teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia de Ribeirão Preto
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans
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.
- Conditions
- Periodontal Disease, Type 2 Diabetes
- Being tested
- Systemic Doxycycline and Sham aPDT, aPDT + Doxycycline Placebo
- Keywords
- Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic Doxycycline and Sham aPDTDrug
Also called aPDT Sham
It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days
aPDT + Doxycycline PlaceboDrug
The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Doxycycline | Active comparator | Not described Receives: Drug: Systemic Doxycycline and Sham aPDT |
| aPDT+ Placebo | Experimental | Not described Receives: Drug: aPDT + Doxycycline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1 month, 3 months and 6 months
Secondary outcomes (1)
Microbial Load
There will be mesaured the changes of microbial load at the proposed experimental times. Microbial load at deep pocket seems to change regarding periodontal treatment and it is expected a reduction after treatment. measuring on various experimental times it will be possible to evaluate treatment stability on reducing periodontopathogens.
Measured: 0, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Arthur Belem Novaes Jr, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595594
- Sponsor's protocol ID
- FAPESP
- Status last verified
- Jul 2014
- First submitted
- 15 Aug 2011
- Last updated
- 16 Jul 2014
- Results posted
- No
Publications
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.
PubMed 18454655Lulic 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.
PubMed 19563331Ramos 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.
PubMed 26710892
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a PDT Protocol With Multiple Applications as an Adjuvant on the Non Surgical Treatment of Periodontal Disease in Patients With Type 2 Diabetes. A Clinical and Laboratorial Study in Humans
- ClinicalTrials.gov ID
- NCT01595594
- Acronym / sponsor ID
- FAPESP
- Conditions
- Periodontal Disease, Type 2 Diabetes
- Keywords
- Periodontal Diseases, Type 2 Diabetes Mellitus, hemoglobin A1c protein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Doxycycline | Active comparator | Drug: Systemic Doxycycline and Sham aPDT |
| aPDT+ Placebo | Experimental | Drug: aPDT + Doxycycline Placebo |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Poorly Controlled Type 2 Diabetes (HbA1c > 7%)
- Advanced Chronic Periodontitis
- Presence of 15 teeth
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic Doxycycline and Sham aPDTAlso: aPDT ShamIt will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days | Drug | Systemic Doxycycline |
| aPDT + Doxycycline PlaceboThe aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days. | Drug | aPDT+ Placebo |
Primary outcome
Clinical Attachment Level
Time frame: 0, 1 month, 3 months and 6 months
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.
1 secondary outcome
Microbial Load
Time frame: 0, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Results publication: PubMed 18454655O'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.
- Results publication: PubMed 19563331Lulic 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.
- Derived from this study: PubMed 26710892Ramos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Periodontal Disease and Type 2 Diabetes, 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 16 Jul 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical Attachment Level (time frame: 0, 1 month, 3 months and 6 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 NCT01595594, 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 16 Jul 2014.