Chronic PeriodontitisNCT02627534
Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis
A study testing Ultrasonic debridement and Antimicrobial photodynamic therapy in people with Chronic Periodontitis and Diabetes Mellitus, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis, Diabetes Mellitus
- What is being tested?
- Ultrasonic debridement and Antimicrobial photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Oct 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type 2 DM for ≥5 years
- DM treatment with oral hypoglycemic agents or insulin supplementation and diet
- glycated hemoglobin (HbA1c) levels from 6.5% to 11%
- at least 15 teeth (excluding third molars and teeth indicated for extraction)
- moderate to severe generalized chronic periodontitis (Armitage, 1999)
- agree and sign the formal consent to participate in the study after receiving an explanation of risks and benefits from an individual who was not a member of the study (Resolution number 196 - October, 1996, and Ethics and Code of Professional Conduct in Dentistry - CFO179/93).
Who cannot join
- medical conditions that required prophylactic antimicrobial coverage
- SRP in the previous 6 months
- antimicrobial therapies in the previous 6 months
- anti-inflammatory therapies in the previous 6 months
- systemic conditions, other than DM, that could affect the progression of chronic periodontitis
- current use of medication that could interfere with periodontal response to treatment
- pregnancy or lactation
- smoking
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ciência e Tecnologia de São José dos Campos - UNESP
Sâo José Dos Campos, São Paulo, 12245-000
About this study
Official title: Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.
Read the detailed description
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Being tested
- Ultrasonic debridement, Antimicrobial photodynamic therapy
- Keywords
- Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes
- Medical subject headings
- Chronic Periodontitis, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic debridementProcedure or surgery
All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
Antimicrobial photodynamic therapyProcedure or surgery
After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic Debridement (UD) | Active comparator | Ultrasonic Debridement (UD) (n=20) Receives: Procedure: Ultrasonic debridement |
| UD + Antimicrobial Photodynamic Therapy | Experimental | Ultrasonic Debridement + aPDT (UD+aPDT) (n=20) Receives: Procedure: Ultrasonic debridement; Procedure: Antimicrobial photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Assessed with manual probe (North Carolina, Hu-Friedy)
Measured: Reductions in Probing Depth was compared at baseline and 180 days
Secondary outcomes (1)
Clinical Attachment Level
Assessed with manual probe (North Carolina, Hu-Friedy)
Measured: Clinical Attachment Level gain was compared at baseline 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 posted11 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionOct 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 Chronic 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nídia Cristina Castro dos Santos, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro P Santamaria, PhD, Study director, ICT - UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627534
- Sponsor's protocol ID
- NSFOSJC
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.
PubMed 27448223
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Effects of Adjunct Photodynamic Therapy in the Treatment of Type 2 Diabetic Patients With Chronic Periodontitis: Split-mouth Randomized Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02627534
- Acronym / sponsor ID
- NSFOSJC
- Conditions
- Chronic Periodontitis, Diabetes Mellitus
- Keywords
- Photodynamic therapy, Ultrasonic debridement, Chronic periodontitis, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Dec 2015 (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.
Periodontal Diseases are considered the sixth complication of Diabetes Mellitus (DM). This close relationship between both diseases is characterized by mutual influence. The presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients.
Detailed description
Diabetes mellitus (DM) has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and costs in public health. The World Health Organization (WHO) estimates that by 2030, 439 million people will suffer from diabetes, around 10% of the world adult population (WHO, 2011). Periodontal Diseases are considered the sixth complication of DM. This close relationship between both diseases is characterized by mutual influence. Thus, an appropriate control of periodontal disease may facilitate the DM control, improving quality of life on diabetes patients. Besides that, the presence of DM might impair prognosis of diverse dental treatments due to its inflammatory nature, negative influence on wound healing, on bone biology, and the establishment of infections. Consequently, knowledge of new dental therapies and the biology of dental treatments for chronic periodontitis in diabetic patients can enhance quality of life and make these treatments more adequate for this common profile of patients. Therefore, the aim of the present study is to investigate the effectiveness of antimicrobial photodynamic therapy as adjunct to full-mouth debridement for the treatment of periodontitis in type 2 diabetic patients through a split-mouth randomized triple-blind clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic Debridement (UD) | Active comparator | Procedure: Ultrasonic debridementUltrasonic Debridement (UD) (n=20) |
| UD + Antimicrobial Photodynamic Therapy | Experimental | Procedure: Ultrasonic debridement, Procedure: Antimicrobial photodynamic therapyUltrasonic Debridement + aPDT (UD+aPDT) (n=20) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of type 2 DM for ≥5 years
- DM treatment with oral hypoglycemic agents or insulin supplementation and diet
- glycated hemoglobin (HbA1c) levels from 6.5% to 11%
- at least 15 teeth (excluding third molars and teeth indicated for extraction)
- moderate to severe generalized chronic periodontitis (Armitage, 1999)
Key exclusion criteria (8 listed)
- medical conditions that required prophylactic antimicrobial coverage
- SRP in the previous 6 months
- antimicrobial therapies in the previous 6 months
- anti-inflammatory therapies in the previous 6 months
- systemic conditions, other than DM, that could affect the progression of chronic periodontitis
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 |
|---|---|---|
| Ultrasonic debridementAll periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist. | Procedure or surgery | UD + Antimicrobial Photodynamic Therapy, Ultrasonic Debridement (UD) |
| Antimicrobial photodynamic therapyAfter ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2. | Procedure or surgery | UD + Antimicrobial Photodynamic Therapy |
Primary outcome
Probing Depth
Time frame: Reductions in Probing Depth was compared at baseline and 180 days
Assessed with manual probe (North Carolina, Hu-Friedy)
1 secondary outcome
Clinical Attachment Level
Time frame: Clinical Attachment Level gain was compared at baseline 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 14 Dec 2015.
- Derived from this study: PubMed 27448223Castro Dos Santos NC, Andere NM, Araujo CF, de Marco AC, Dos Santos LM, Jardini MA, Santamaria MP. Local adjunct effect of antimicrobial photodynamic therapy for the treatment of chronic periodontitis in type 2 diabetics: split-mouth double-blind randomized controlled clinical trial. Lasers Med Sci. 2016 Nov;31(8):1633-1640. doi: 10.1007/s10103-016-2030-8. Epub 2016 Jul 22.
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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.
Mauro P Santamaria, PhD study director
ICT - UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic debridement and Antimicrobial photodynamic therapy in people with Chronic Periodontitis and Diabetes Mellitus, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 6 inclusion and 8 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 14 Dec 2015. 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.
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?
Probing Depth (time frame: Reductions in Probing Depth was compared at baseline and 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 NCT02627534, 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 14 Dec 2015.