PeriodontitisPDTDMT2NCT01964833
PDT and Periodontal Treatment in DMT2 Patients
A study testing Periodontal treatment and Periodontal treatment and PDT in people with Periodontitis and Diabetes Mellitus Type 2, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Diabetes Mellitus Type 2
- What is being tested?
- Periodontal treatment and Periodontal treatment and PDT
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Dec 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Photodynamic Therapy and Periodontal Treatment in Patients With Type 2 Diabetes Mellitus: Randomized, Double-blind Clinical Trial
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.
Read the detailed description
Randomization of the patients to the different groups will be performed with the appropriate software program. Only the lead researcher will have access to the randomization list. Allocation to the two groups will be carried out in blocks of four.
The patients will be sent to Operator A for the periodontal exam. Without knowledge of the results of this exam, the patients will be treated by Operators B and C for periodontal treatment, which will involve oral hygiene instructions as well as supra-gingival and sub-gingival scaling and planing in up to four sessions. At the end of each session, the patients will be sent to Operator D, who will administer either placebo or active PDT based on the content of the sealed envelope. Thus, both the patients and operator in charge of the periodontal exams will be blinded to the PDT protocol (double-blind study).
Fasting blood sugar and glycated hemoglobin exams will be performed at baseline as well as 15, 30, 90 and 180 days after the completion of treatment. All exams will be carried out at the same laboratory affiliated with the university.
The clinical periodontal exams will be performed by a single examiner specialized in periodontics, who will evaluate six regions of each tooth with a 15-mm probe (North Carolina model, Hu-Friedy, Chicago, IL, USA). The following aspects will be recorded: plaque index, bleeding upon probing, probing depth, gingival recession and attachment loss (Armitage, 2004). Evaluations will be carried out performed at baseline (prior to initial treatment) as well as 15, 30, 90 and 180 days after the completion of treatment.
Patients will receive periodontal treatment and photodynamic therapy (active or sham depending on the allocation).
Crevicular fluid will be collected from the previously defined sites with a probing depth equal to or greater than 4 mm that will receive treatment. Collection will be performed with relative isolation using cotton rolls following the removal of supra-gingival plaque with periodontal curettes and air drying for five seconds. Absorbent paper strips (PerioPaper, ProFlow Inc., Amityville, NY, USA) will be individually inserted into each site for 30 seconds (Rudin et al., 1970). The collections will be performed by a single researcher. The volume of crevicular fluid samples will be measured using the Periotron 8000 micro-moisture meter (Oraflow Inc., NY, USA). The samples will then be placed in duly identified sterile plastic microtubes, temporarily stored in dry ice and subsequently stored in a freezer at -80 ºC
- Conditions
- Periodontitis, Diabetes Mellitus Type 2
- Being tested
- Periodontal treatment, Periodontal treatment and PDT
- Keywords
- clinical trial, DMT2, periodontitis, PDT
- Medical subject headings
- Periodontitis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
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 and PDTProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal treatment | Sham comparator | Conventional periodontal treatment with hygiene orientation, calculus removal and root scaling and planing. Sham PDT. Receives: 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 Receives: Procedure: Periodontal treatment and PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (2)
Changes in the fasting blood and glycated hemoglobin (HBA1C)
These tests reflects the glycemic control at the moment of the dental exam and the average blood sugar level for the past two to three months.
Measured: Baseline, 15, 30, 90 and 180 days
Cytokines in the crevicular fluid
The crevicular fluid will be collected and investigated for the presence of IL-1, IL-6, TNF-alfa, osteocalcin, osteoprotegerin/RANKL in the crevicular fluid.
Measured: Baseline, 15, 30, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Miranda Franca, University of Nove de Julho
- Investigators
- Cristiane M Franca, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964833
- Sponsor's protocol ID
- 375.454
- Other IDs
- 375.454
- Acronym
- PDTDMT2
- Status last verified
- Aug 2016
- First submitted
- 10 Oct 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26013003
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Photodynamic Therapy and Periodontal Treatment in Patients With Type 2 Diabetes Mellitus: Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01964833
- Acronym / sponsor ID
- PDTDMT2 / 375.454
- Conditions
- Periodontitis, Diabetes Mellitus Type 2
- Keywords
- clinical trial, DMT2, periodontitis, PDT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Oct 2013 (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 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.
Detailed description
Randomization of the patients to the different groups will be performed with the appropriate software program. Only the lead researcher will have access to the randomization list. Allocation to the two groups will be carried out in blocks of four.
The patients will be sent to Operator A for the periodontal exam. Without knowledge of the results of this exam, the patients will be treated by Operators B and C for periodontal treatment, which will involve oral hygiene instructions as well as supra-gingival and sub-gingival scaling and planing in up to four sessions. At the end of each session, the patients will be sent to Operator D, who will administer either placebo or active PDT based on the content of the sealed envelope. Thus, both the patients and operator in charge of the periodontal exams will be blinded to the PDT protocol (double-blind study).
Fasting blood sugar and glycated hemoglobin exams will be performed at baseline as well as 15, 30, 90 and 180 days after the completion of treatment. All exams will be carried out at the same laboratory affiliated with the university.
The clinical periodontal exams will be performed by a single examiner specialized in periodontics, who will evaluate six regions of each tooth with a 15-mm probe (North Carolina model, Hu-Friedy, Chicago, IL, USA). The following aspects will be recorded: plaque index, bleeding upon probing, probing depth, gingival recession and attachment loss (Armitage, 2004). Evaluations will be carried out performed at baseline (prior to initial treatment) as well as 15, 30, 90 and 180 days after the completion of treatment.
Patients will receive periodontal treatment and photodynamic therapy (active or sham depending on the allocation).
Crevicular fluid will be collected from the previously defined sites with a probing depth equal to or greater than 4 mm that will receive treatment. Collection will be performed with relative isolation using cotton rolls following the removal of supra-gingival plaque with periodontal curettes and air drying for five seconds. Absorbent paper strips (PerioPaper, ProFlow Inc., Amityville, NY, USA) will be individually inserted into each site for 30 seconds (Rudin et al., 1970). The collections will be performed by a single researcher. The volume of crevicular fluid samples will be measured using the Periotron 8000 micro-moisture meter (Oraflow Inc., NY, USA). The samples will then be placed in duly identified sterile plastic microtubes, temporarily stored in dry ice and subsequently stored in a freezer at -80 ºC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal treatment | Sham comparator | Procedure: Periodontal treatmentConventional periodontal treatment with hygiene orientation, calculus removal and root scaling and planing. Sham PDT. |
| Periodontal Treatment and PDT | Experimental | Procedure: Periodontal treatment and PDTConventional periodontal treatment with hygiene orientation, calculus removal, root scaling and planing. Active PDT with diode laser and methylene blue photosensitizer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Uncompensated diabetes, based on SBD criteria;
- Smoking habit in 12 months prior to treatment;
- Anemia;
- Active cancer;
- Current pregnancy;
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 |
|---|---|---|
| Periodontal treatmentPeriodontal 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. | Procedure or surgery | Periodontal treatment |
| Periodontal treatment and PDTPatients 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. | Procedure or surgery | Periodontal Treatment and PDT |
Primary outcome
Change in the clinical attachment level at 180 days.
Time frame: 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.
2 secondary outcomes
Changes in the fasting blood and glycated hemoglobin (HBA1C)
Time frame: Baseline, 15, 30, 90 and 180 days
Cytokines in the crevicular fluid
Time frame: Baseline, 15, 30, 90 and 180 days
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 9 Aug 2016.
- Derived from this study: PubMed 26013003Evangelista 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.
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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.
Cristiane M Franca, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal treatment and Periodontal treatment and PDT in people with Periodontitis and Diabetes Mellitus Type 2, run by University of Nove de Julho 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 5 inclusion and 9 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 9 Aug 2016. 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.
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 the clinical attachment level at 180 days. (time frame: 180 days). 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 NCT01964833, which also lists 1 linked publication.
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 9 Aug 2016.