N/A
N=31
Peri-implantitis Treatment: Clinical Results of Conventional Treatment vs. the Addition of Biolase
Peri-Implantitis
Bottom Line
View on ClinicalTrials.gov: NCT03544515 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Probing Depth (PD) — -0.73; -1.36 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Er,Cr:YSGG laser (Device); Scaling (Procedure); Inactive Er,Cr:YSGG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Probing Depth (PD) |
-0.73; -1.36 | — |
| SECONDARY Change in Radiographic Bone Loss Around the Implant |
0.02; 0.05 | — |
| SECONDARY Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP) |
-20; -36 | — |
| SECONDARY Presence of Suppuration on Probing |
— | — |
| SECONDARY Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque |
-30; -29 | — |
| SECONDARY Mobility: Mean Change in the Clinical Attachment Level (CAL) |
-1.2; -0.90 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03544515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.