Type 2 Diabetes MellitusPhase 2/3NCT04857346
Antimicrobial Photodynamic Therapy in Chronic Periodontitis and Diabetes Mellitus
A Phase 2/3 study testing Indocyanine green in people with Type 2 Diabetes Mellitus and Prediabetic State, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Prediabetic State, Chronic Periodontitis
- What is being tested?
- Indocyanine green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2020to 1 Feb 2021
- Phase
- Phase 2/3
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged ≥30 years
- clinically diagnosed with mild to moderate periodontitis
- self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5%
- patients who complied with the treatment protocol.
Who cannot join
- pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
College of Applied Medical Sciences, King Saud University
Riyadh, 11454
About this study
Official title: Indocyanine-mediated Antimicrobial Photodynamic Therapy Promotes Superior Clinical Effects in Stage III and Grade C Chronic Periodontitis Among Different Forms of Diabetes Mellitus: A Randomized Controlled Clinical Trial
With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.
- Being tested
- Indocyanine green
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called Photodynamic therapy
Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.
| Study group | Role | What they receive |
|---|---|---|
| Controlled Type 2 diabetes mellitus | Experimental | Not described Receives: Drug: Indocyanine green |
| Uncontrolled Type 2 diabetes melltius | Experimental | Not described Receives: Drug: Indocyanine green |
| Non-diabetic patients | Active comparator | Not described Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva.
Measured: 6 months
Clinical attachment level
Clinical attachment level will be measured by adding recession with probing depth
Measured: 6 months
Secondary outcomes (4)
Plaque scores
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Measured: 6 months
Bleeding on probing
Dichotomous scoring to each site of the tooth as '1 - present' and '0 - absent'
Measured: 6 months
Porphyromonas gingivalis
Presence or absence of bacteria from the plaque biofilms in the patient
Measured: 6 months
Interleukin-6
Proinflammatory cytokine levels that will be quantified in the laboratory.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Jun 2020
- Primary completion12 Dec 2020
- Study completion1 Feb 2021
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 Type 2 Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mahmoud Al-Momani, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857346
- Sponsor's protocol ID
- KSU334
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Momani MM. Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102379. doi: 10.1016/j.pdpdt.2021.102379. Epub 2021 Jun 1.
PubMed 34087466
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine-mediated Antimicrobial Photodynamic Therapy Promotes Superior Clinical Effects in Stage III and Grade C Chronic Periodontitis Among Different Forms of Diabetes Mellitus: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04857346
- Acronym / sponsor ID
- KSU334
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 23 Apr 2021 (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.
With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controlled Type 2 diabetes mellitus | Experimental | Drug: Indocyanine green |
| Uncontrolled Type 2 diabetes melltius | Experimental | Drug: Indocyanine green |
| Non-diabetic patients | Active comparator | Drug: Indocyanine green |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged ≥30 years
- clinically diagnosed with mild to moderate periodontitis
- self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5%
- patients who complied with the treatment protocol.
Key exclusion criteria (1 listed)
- pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.
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 |
|---|---|---|
| Indocyanine greenAlso: Photodynamic therapySingle application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues. | Drug | Controlled Type 2 diabetes mellitus, Non-diabetic patients, Uncontrolled Type 2 diabetes melltius |
Primary outcome
Probing depth
Time frame: 6 months
Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva.
Clinical attachment level
Time frame: 6 months
Clinical attachment level will be measured by adding recession with probing depth
4 secondary outcomes
Plaque scores
Time frame: 6 months
Bleeding on probing
Time frame: 6 months
Porphyromonas gingivalis
Time frame: 6 months
Interleukin-6
Time frame: 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 23 Apr 2021.
- Derived from this study: PubMed 34087466Al-Momani MM. Indocyanine-mediated antimicrobial photodynamic therapy promotes superior clinical effects in stage III and grade C chronic periodontitis among controlled and uncontrolled diabetes mellitus: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102379. doi: 10.1016/j.pdpdt.2021.102379. Epub 2021 Jun 1.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing Indocyanine green in people with Type 2 Diabetes Mellitus and Prediabetic State, run by King Saud University at 1 site in Saudi Arabia.
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 1 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 23 Apr 2021. 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 Saudi Arabia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Probing depth (time frame: 6 months). The study lists 2 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 NCT04857346, 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 23 Apr 2021.