Peri-ImplantitisPhase 1NCT04833569
ICG-PDT, Periimplantitis, Diabetes Mellitus
A Phase 1 study testing ICG-PDT and peri-implant mechanical debridement in people with Peri-Implantitis, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- ICG-PDT and peri-implant mechanical debridement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Sep 2020to 10 Mar 2021
- Phase
- Phase 1
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients above 45 years of age having type 2 DM
- HbA1c (≥6.5%) and fasting glucose test
- probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ
- On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.
- Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial
In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis
- Conditions
- Peri-Implantitis
- Being tested
- ICG-PDT, peri-implant mechanical debridement
- Keywords
- photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*
- Medical subject headings
- Peri-Implantitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-PDTBiological
An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients
peri-implant mechanical debridementDevice
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green mediated photodynamic therapy (ICG-PDT) | Experimental | Delivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. Receives: Biological: ICG-PDT; Device: peri-implant mechanical debridement |
| Peri-implant mechanical debridement | Placebo comparator | Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip. Receives: Device: peri-implant mechanical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Presence or absence of bleeding indicated as '1' or '0', respectively
Measured: 6 months
Plaque index
Presence or absence of plaque indicated as '1' or '0', respectively.
Measured: 6 months
Probing depth
Measurement of consecutive millimeter markings of the periodontal pocket depth
Measured: 6 months
Suppuration
Presence or absence of pus
Measured: 6 months
Crestal bone loss
Measurement of consecutive millimeter markings of the alveolar bone levels
Measured: 6 months
Secondary outcomes (5)
Microbiological analysis (Porphyromonas gingivalis)
Bacterial viability from the peri-implant plaque
Measured: 6 months
Microbiological analysis (Treponema denticola)
Bacterial viability from the peri-implant plaque
Measured: 6 months
HbA1c
Assessment of serum HbA1c
Measured: 6 months
Interleukin-1 beta
Assessment from peri-implant crevicular fluid
Measured: 6 months
Interleukin-6
Assessment from peri-implant crevicular fluid
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 posted6 Apr 2021
- Study start20 Sep 2020
- Primary completion15 Feb 2021
- Study completion10 Mar 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 Peri-ImplantitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Labban Nawwaf, King Saud University
- Investigators
- Nawwaf Labban, BDS MSD PhD, Principal investigator, Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833569
- Sponsor's protocol ID
- KingSaud
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.
PubMed 34033934
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04833569
- Acronym / sponsor ID
- KingSaud
- Conditions
- Peri-Implantitis
- Keywords
- photodynamic therapy*, periimplantitis*, diabetes mellitus*, indocyanine green*, photosensitizer*
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 6 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.
In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green mediated photodynamic therapy (ICG-PDT) | Experimental | Biological: ICG-PDT, Device: peri-implant mechanical debridementDelivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. |
| Peri-implant mechanical debridement | Placebo comparator | Device: peri-implant mechanical debridementNon-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ICG-PDTAn 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients | Biological | Indocyanine green mediated photodynamic therapy (ICG-PDT) |
| peri-implant mechanical debridementThe peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany). | Device | Indocyanine green mediated photodynamic therapy (ICG-PDT), Peri-implant mechanical debridement |
Primary outcome
Bleeding on probing
Time frame: 6 months
Presence or absence of bleeding indicated as '1' or '0', respectively
Plaque index
Time frame: 6 months
Presence or absence of plaque indicated as '1' or '0', respectively.
Probing depth
Time frame: 6 months
Measurement of consecutive millimeter markings of the periodontal pocket depth
Suppuration
Time frame: 6 months
Presence or absence of pus
Crestal bone loss
Time frame: 6 months
Measurement of consecutive millimeter markings of the alveolar bone levels
5 secondary outcomes
Microbiological analysis (Porphyromonas gingivalis)
Time frame: 6 months
Microbiological analysis (Treponema denticola)
Time frame: 6 months
HbA1c
Time frame: 6 months
Interleukin-1 beta
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 6 Apr 2021.
- Derived from this study: PubMed 34033934Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.
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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.
Nawwaf Labban, BDS MSD PhD principal investigator
Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICG-PDT and peri-implant mechanical debridement in people with Peri-Implantitis, 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 5 inclusion and 0 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 6 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Bleeding on probing (time frame: 6 months). The study lists 5 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 NCT04833569, 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 6 Apr 2021.