Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03544515 |
| Other study ID # |
AAAR8727 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2019 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to observe the effects of two commonly utilized treatment
modalities to treat peri-implantitis and to compare the results. The first method of
treatment is debridement with curettes and ultrasonic scalers and it represents the
traditional approach in the treatment of peri-implantitis. The second method of treatment
involves the use of the Biolase laser in addition to the traditional approach of debriding
with curettes and ultrasonic scalers. No studies exist comparing these two approaches, and
this will serve as a pilot study to explore possible differences.
Our research hypothesis is that the addition of Er;Cr;YSGG laser is likely to be more
effective in removing the microbiota from a rough implant surface, and that this will
manifest with improved clinical parameters in subjects that receive this method of treatment.
Description:
This clinical study will involve 26 human subjects pre-screened at Columbia University. The
patient will have at least one implant presenting with early to moderate peri-implantitis.
Peri-implantitis has been defined as an implant restoration with inflamed bleeding gingiva,
probing depths around the implant of 5-8mm, bone loss and exposure of threads around the
implant (limited to one-third of the threads exposed). The purpose of this study is to
determine the benefits of treating peri-implantitis with a closed laser approach known as the
"Repair Protocol" using an Er,Cr:YSGG laser compared with traditional non-surgical therapy.
Each subject, when determined to fall under the parameters of the study for peri-implantitis,
will be randomly assigned to one of two groups: the test Er,Cr:YSGG laser group or the
control group.
The study will constitute a human double-blind randomized clinical trial in which both
examiners and patients will be blinded to the treatment. In order to ensure the blinding of
the patients, the laser will be applied to all implants, although the it will not be
activated in the control group. The therapist will be the same person throughout the study
while the examiners will be calibrated.
The two groups that will constitute the study and the procedures that will be applied are:
Experimental: Scaling and root planning with an ultrasonic or piezoelectric instrument and
hand instrumentation with hand instruments. No prosthetic components will be removed .
Application of laser therapy following the specifics of the company.
Control: Scaling and root planning with an ultrasonic or piezoelectric instrument and hand
instrumentation with hand instruments. A sham, inactivated laser, treatment will be
delivered.
After the treatment, the patients will be followed-up after 1 week, 3, 6 and 9 months.
Periapical X-rays will be taken at baseline and 9 months follow-up appointments.
Data to be collected include: Primary outcome measures will include: presence of bleeding on
probing, probing depth, and the progression of bone loss around the implant, as measured with
bone sounding under local anesthesia and radiographically with the aid of a stent. Secondary
outcome measures will include: Gingival index (GI), Plaque Index, mobility, and suppuration.
