Clinical trial NCT03544515: Peri-implantitis Treatment: Clinical Results of Conventional Treatment vs. the Addition of Biolase
Official title: Treatment of Peri-implantitis: Clinical Comparison Between Conventional Treatment Versus Conventional Plus Biolase Laser Treatment as a Co-adjuvant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: peri-implantitis
laser treatment
Biolase
Er,Cr:YSGG
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Biolase Inc
First posted: 2018-06-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized clinical trial
Primary purpose: TREATMENT

Brief 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. The 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Presence of at least one implant presenting with early to moderate peri-implantitis
* Peri-implantitis 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).
* Medically healthy non-smokers with no previous periodontal treatment other than routine maintenance
* Patients with diabetes were only included if they reported an HbA1C of 7% or less within the past 3 months

Exclusion Criteria:

* Mobility of the implant
* Peri-implantitis treatment rendered in the last 3 months

Primary outcomes:
measure: Change in Probing Depth (PD)
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Change in Radiographic Bone Loss Around the Implant
timeFrame: Baseline, 9 months
measure: Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)
timeFrame: Baseline, 9 months
measure: Presence of Suppuration on Probing
timeFrame: 9 months
measure: Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque
timeFrame: Baseline, 9 months
measure: Mobility: Mean Change in the Clinical Attachment Level (CAL)
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Dental Medicine
state: New York
Study officials:
affiliation: Columbia University College of Dental Medicine
name: Philip Kang, DDS
role: PRINCIPAL_INVESTIGATOR
References: