Periodontal DiseasesNCT05816941
Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus
A study testing Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in people with Periodontal Diseases and Diabetes Mellitus, Type 2, run by University of Ljubljana.
Trial summary
Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis
- What is being tested?
- Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2016to 3 Jan 2019
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 75 years
- Diabetes Mellitus type 2 with an HbA1c value > 7.0%,
- At least ten teeth in the Maxilla and Mandible
- At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing.
Who cannot join
- Antibiotic treatment in the last four months
- Periodontal treatment in the last six months
- Any change in Antihyperglycaemic treatment three months prior to participation
- Pregnant women
- Lactating women
- Smokers
- Former smokers who had stopped smoking less than five years before participation
About this study
Official title: The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM).
Clinical Relevance: aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome.
Read the detailed description
Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis. However, periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators.
Methods:
Twenty-four patients with T2DM were enrolled in the study. Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI) and sulcus bleeding index (SBI). Glycated haemoglobin A1c (HbA1c) was measured. To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans, Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips. Patients were randomly divided into the test and control group. In the test group, complete oral disinfection was performed in combination with aPTD. In the control group, only complete oral disinfection was performed.
- Conditions
- Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Inflammation
- Being tested
- Conventional Periodontal Treatment (Complete Oral Disinfection), Adjunctive Photodynamic Therapy
- Keywords
- Type 2 Diabetes Mellitus, Periodontal Disease, Antimicrobial Photodynamic Therapy, Indocyanine Green
- Medical subject headings
- Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis, Periodontal Pocket, Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Periodontal Treatment (Complete Oral Disinfection)Procedure or surgery
Oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose.
For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
Adjunctive Photodynamic TherapyProcedure or surgery
Photodynamic Therapy as adjunctive treatment in pockets with PPD ≥ 5 mm. For this purpose, a Fotona XD -2 diode laser (Fotona, Ljubljana, Slovenia) with a wavelength of 810 nm, a power of 250 mW and the photosensitizing agent indocyanine green at a concentration of 1 mg/ml was used. First, the area to be irradiated was isolated, and the photosensitizing agent was applied to the periodontal pocket. After 60 seconds, the supragingival excess of the photosensitizing agent was removed by gentle rinsing with a saline solution. This was followed by irradiation for ten seconds on each side.
For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | Conventional Periodontal Treatment: Complete Oral Disinfection. Receives: Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection) |
| Experimental Arm | Experimental | Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm. Receives: Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection); Procedure: Adjunctive Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth (PPD)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Measured: At baseline
Probing pocket depth (PPD)
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Measured: 90 days after treatment
Bleeding on probing (BOP)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Measured: At baseline
Bleeding on probing (BOP)
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Measured: 90 days after treatment
Clinical attachment level (CAL)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Measured: At baseline
Clinical attachment level (CAL)
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Measured: 90 days after treatment
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
Measured: At baseline
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
Measured: 90 days after treatment
HbA1c test
Blood sample. Unit %
Measured: At baseline
HbA1c test
Blood sample. Unit %
Measured: 90 days after treatment
Secondary outcomes (4)
Plaque index (PI)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Measured: At baseline
Plaque index (PI)
Yes/No at six sites around each tooth. Unit: % (sites with plaque/all sites)
Measured: 90 days after treatment
Sulcus bleeding index (SBI)
es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
Measured: At baseline
Sulcus bleeding index (SBI)
es/No at six sites around each tooth. Unit: % (sites with Sulcus bleeding/all sites)
Measured: 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start3 Jan 2016
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Model description
- Test and Control group. All patients received oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. Afterwards, the patients were randomly divided into test and control groups. The patients in the test group received aPDT as adjuvant treatment in pockets with PPD ≥ 5 mm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Rok Schara, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816941
- Sponsor's protocol ID
- aPTD in Pariodontal Treatment
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
Publications
Monzavi A, Chinipardaz Z, Mousavi M, Fekrazad R, Moslemi N, Azaripour A, Bagherpasand O, Chiniforush N. Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial. Photodiagnosis Photodyn Ther. 2016 Jun;14:93-7. doi: 10.1016/j.pdpdt.2016.02.007. Epub 2016 Feb 24.
PubMed 26921460Braun 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 18713259Lulic 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 19563331Polansky R, Haas M, Heschl A, Wimmer G. Clinical effectiveness of photodynamic therapy in the treatment of periodontitis. J Clin Periodontol. 2009 Jul;36(7):575-80. doi: 10.1111/j.1600-051x.2009.01412.x.
PubMed 19554711Ge L, Shu R, Li Y, Li C, Luo L, Song Z, Xie Y, Liu D. Adjunctive effect of photodynamic therapy to scaling and root planing in the treatment of chronic periodontitis. Photomed Laser Surg. 2011 Jan;29(1):33-7. doi: 10.1089/pho.2009.2727. Epub 2010 Dec 18.
PubMed 21166588Castro 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 27448223Brinar S, Skvarca A, Gaspirc B, Schara R. The effect of antimicrobial photodynamic therapy on periodontal disease and glycemic control in patients with type 2 diabetes mellitus. Clin Oral Investig. 2023 Oct;27(10):6235-6244. doi: 10.1007/s00784-023-05239-0. Epub 2023 Sep 6.
PubMed 37672083
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05816941
- Acronym / sponsor ID
- aPTD in Pariodontal Treatment
- Conditions
- Periodontal Diseases, Diabetes Mellitus, Type 2, Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Inflammation
- Keywords
- Type 2 Diabetes Mellitus, Periodontal Disease, Antimicrobial Photodynamic Therapy, Indocyanine Green
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 3 Jan 2016 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 18 Apr 2023 (actual)
- 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.
Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM).
Clinical Relevance: aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome.
Detailed description
Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis. However, periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators.
Methods:
Twenty-four patients with T2DM were enrolled in the study. Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI) and sulcus bleeding index (SBI). Glycated haemoglobin A1c (HbA1c) was measured. To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans, Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips. Patients were randomly divided into the test and control group. In the test group, complete oral disinfection was performed in combination with aPTD. In the control group, only complete oral disinfection was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Test and Control group. All patients received oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. Afterwards, the patients were randomly divided into test and control groups. The patients in the test group received aPDT as adjuvant treatment in pockets with PPD ≥ 5 mm.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection)Conventional Periodontal Treatment: Complete Oral Disinfection. |
| Experimental Arm | Experimental | Procedure: Conventional Periodontal Treatment (Complete Oral Disinfection), Procedure: Adjunctive Photodynamic TherapyConventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in periodontal pockets with PPD ≥ 5 mm. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40 and 75 years
- Diabetes Mellitus type 2 with an HbA1c value > 7.0%,
- At least ten teeth in the Maxilla and Mandible
- At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing.
Key exclusion criteria (7 listed)
- Antibiotic treatment in the last four months
- Periodontal treatment in the last six months
- Any change in Antihyperglycaemic treatment three months prior to participation
- Pregnant women
- Lactating women
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 |
|---|---|---|
| Conventional Periodontal Treatment (Complete Oral Disinfection)Oral hygiene instructions followed by complete oral disinfection (removal of hard and soft deposits, scaling and root planing, mouth rinse with 0.2% chlorhexidine twice in one minute, pocket rinse with 0.2% chlorhexidine three times in ten minutes). Ultrasonic (Piezoled, KaVo) and hand instruments (Gracey curettes, Hu-Friedy, USA) were used for this purpose. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine. | Procedure or surgery | Control Arm, Experimental Arm |
| Adjunctive Photodynamic TherapyPhotodynamic Therapy as adjunctive treatment in pockets with PPD ≥ 5 mm. For this purpose, a Fotona XD -2 diode laser (Fotona, Ljubljana, Slovenia) with a wavelength of 810 nm, a power of 250 mW and the photosensitizing agent indocyanine green at a concentration of 1 mg/ml was used. First, the area to be irradiated was isolated, and the photosensitizing agent was applied to the periodontal pocket. After 60 seconds, the supragingival excess of the photosensitizing agent was removed by gentle rinsing with a saline solution. This was followed by irradiation for ten seconds on each side. For the next 14 days, all patients were asked to rinse their oral cavities twice daily with 0.12% chlorhexidine. | Procedure or surgery | Experimental Arm |
Primary outcome
Probing pocket depth (PPD)
Time frame: At baseline
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Probing pocket depth (PPD)
Time frame: 90 days after treatment
Probing pocket depth measured using manual probe at 6 sites around each tooth. Unit: millimeters
Bleeding on probing (BOP)
Time frame: At baseline
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Bleeding on probing (BOP)
Time frame: 90 days after treatment
Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % (bleeding sites/all sites)
Clinical attachment level (CAL)
Time frame: At baseline
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
Clinical attachment level (CAL)
Time frame: 90 days after treatment
This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. Unit: millimeters
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
Time frame: At baseline
Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
The presence of five periodontal pathogens, Aggregatibacter actinomycetemcomitans (AA), Porphyromonas gingivalis (PG), Prevotella intermedia (PI), Tanerella forsythia (TF) and Treponema denticola (TD),
Time frame: 90 days after treatment
Plaque samples were collected with sterile paper tips after supragingival soft and hard debris had been removed according to the manufacturer's instructions. Analysis by Polymerase chain reaction (PCR) followed by hybridization against species-specific DNA probes. According to the manufacturer, the cut-off of the test is set at 10³ to 10⁴ genome equivalents
HbA1c test
Time frame: At baseline
Blood sample. Unit %
HbA1c test
Time frame: 90 days after treatment
Blood sample. Unit %
4 secondary outcomes
Plaque index (PI)
Time frame: At baseline
Plaque index (PI)
Time frame: 90 days after treatment
Sulcus bleeding index (SBI)
Time frame: At baseline
Sulcus bleeding index (SBI)
Time frame: 90 days after treatment
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 18 May 2023.
- Background: PubMed 26921460Monzavi A, Chinipardaz Z, Mousavi M, Fekrazad R, Moslemi N, Azaripour A, Bagherpasand O, Chiniforush N. Antimicrobial photodynamic therapy using diode laser activated indocyanine green as an adjunct in the treatment of chronic periodontitis: A randomized clinical trial. Photodiagnosis Photodyn Ther. 2016 Jun;14:93-7. doi: 10.1016/j.pdpdt.2016.02.007. Epub 2016 Feb 24.
- Background: PubMed 18713259Braun 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.
- Background: 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.
- Background: PubMed 19554711Polansky R, Haas M, Heschl A, Wimmer G. Clinical effectiveness of photodynamic therapy in the treatment of periodontitis. J Clin Periodontol. 2009 Jul;36(7):575-80. doi: 10.1111/j.1600-051x.2009.01412.x.
- Background: PubMed 21166588Ge L, Shu R, Li Y, Li C, Luo L, Song Z, Xie Y, Liu D. Adjunctive effect of photodynamic therapy to scaling and root planing in the treatment of chronic periodontitis. Photomed Laser Surg. 2011 Jan;29(1):33-7. doi: 10.1089/pho.2009.2727. Epub 2010 Dec 18.
- Background: 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.
- Derived from this study: PubMed 37672083Brinar S, Skvarca A, Gaspirc B, Schara R. The effect of antimicrobial photodynamic therapy on periodontal disease and glycemic control in patients with type 2 diabetes mellitus. Clin Oral Investig. 2023 Oct;27(10):6235-6244. doi: 10.1007/s00784-023-05239-0. Epub 2023 Sep 6.
- Individual participant dataSharing planned: No. All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.
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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.
Rok Schara study director
Assistant Professor
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Periodontal Treatment (Complete Oral Disinfection) and Adjunctive Photodynamic Therapy in people with Periodontal Diseases and Diabetes Mellitus, Type 2, run by University of Ljubljana.
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 4 inclusion and 7 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 pocket depth (PPD) (time frame: At baseline). The study lists 10 primary outcomes in all. 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 NCT05816941, which also lists 7 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 18 May 2023.