A Phase 1 interventional study of ICG-PDT and peri-implant mechanical debridement in Peri-Implantitis, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by King Saud University · Phase 1, Interventional, and Treatment
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
304 studies on the registry are indexed under Peri-Implantitis; 83 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 182 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
Biological: ICG-PDT · Device: peri-implant mechanical debridement
Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.
Device: peri-implant mechanical debridement
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
The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
Bleeding on probing
Presence or absence of bleeding indicated as '1' or '0', respectively
Time frame: 6 months
Plaque index
Presence or absence of plaque indicated as '1' or '0', respectively.
Time frame: 6 months
Probing depth
Measurement of consecutive millimeter markings of the periodontal pocket depth
Time frame: 6 months
Suppuration
Presence or absence of pus
Time frame: 6 months
Crestal bone loss
Measurement of consecutive millimeter markings of the alveolar bone levels
Time frame: 6 months
Microbiological analysis (Porphyromonas gingivalis)
Bacterial viability from the peri-implant plaque
Time frame: 6 months
Microbiological analysis (Treponema denticola)
Bacterial viability from the peri-implant plaque
Time frame: 6 months
HbA1c
Assessment of serum HbA1c
Time frame: 6 months
Interleukin-1 beta
Assessment from peri-implant crevicular fluid
Time frame: 6 months
Interleukin-6
Assessment from peri-implant crevicular fluid
Time frame: 6 months
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King Saud University