An interventional study of Er,Cr:YSGG laser and Scaling in Peri-Implantitis, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Columbia University · Not applicable, Interventional, and Treatment
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.
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.
313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 191 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
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Exclusion Criteria:
Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an inactive fashion
Procedure: Scaling · Device: Inactive Er,Cr:YSGG
Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an active fashion
Device: Er,Cr:YSGG laser · Procedure: Scaling
Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing
Also known as: Biolase (Biolase, Inc)
Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)
Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant
Change in Probing Depth (PD)
Measured in mm with a manual periodontal probe (UNC-15). Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
Time frame: Baseline, 9 months
Change in Radiographic Bone Loss Around the Implant
Measured with calibrated (taken with a positioning device) peri-apical X-rays. Radiographic bone loss is measured as distance from the platform of the implant to the crest of the bone in the mesial and distal sites. The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
Time frame: Baseline, 9 months
Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
Time frame: Baseline, 9 months
Presence of Suppuration on Probing
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic
Time frame: 9 months
Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
Time frame: Baseline, 9 months
Mobility: Mean Change in the Clinical Attachment Level (CAL)
CAL is an indicator of the stability of the implant. CAL is measured in mm as distance from the cemento-enamel junction to the gingival margin.
Time frame: Baseline, 9 months
| Milestone | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Started | 16 | 15 |
| Completed | 10 | 13 |
| Not completed | 6 | 2 |
| Withdrew: Didn't complete study follow-up due to pandemic pause in research activity | 4 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 |
Measured in mm with a manual periodontal probe (UNC-15). Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
| mm | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Change in Probing Depth (PD) | -0.73 (-1.17 to 0.28) | -1.36 (-1.96 to 0.77) |
Measured with calibrated (taken with a positioning device) peri-apical X-rays. Radiographic bone loss is measured as distance from the platform of the implant to the crest of the bone in the mesial and distal sites. The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
| mm | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Change in Radiographic Bone Loss Around the Implant | 0.02 (-0.56 to 0.61) | 0.05 (-0.80 to 0.91) |
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
| percentage of bleeding | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP) | -20 (-37 to -2) | -36 (-61 to -1) |
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic
No measurements were reported for this outcome.
Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). The average of all sites for all implants (26 implants in the Inactive Arm; 38 implants in the Active Arm) is reported.
| percentage of plaque | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque | -30 (-50 to -8) | -29 (-54 to -2) |
CAL is an indicator of the stability of the implant. CAL is measured in mm as distance from the cemento-enamel junction to the gingival margin.
| mm | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG |
|---|---|---|
| Mobility: Mean Change in the Clinical Attachment Level (CAL) | -1.2 (-1.97 to -0.36) | -0.90 (-1.34 to -0.47) |
Collected over Up to 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Scaling and Use of Inactive Er,Cr:YSGG | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Scaling and Use of Active Er,Cr:YSGG | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG | Total |
|---|---|---|---|
| Mean | 67.19 ± 9.26 | 62.53 ± 7.12 | 64.93 ± 8.49 |
| Sex: Female, Male(Participants) | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 12 | 13 | 25 |
| Race and Ethnicity Not Collected(Participants) | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG | Total |
|---|---|---|---|
| United States | 16 | 15 | 31 |
| Implant Prosthesis(implants) | Scaling and Use of Inactive Er,Cr:YSGG | Scaling and Use of Active Er,Cr:YSGG | Total |
|---|---|---|---|
| screw-retained | 19 | 8 | 27 |
| cement-retained | 41 | 20 | 61 |
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