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| Name | Class |
|---|---|
| Biolase Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling and use of inactive Er,Cr:YSGG | Sham Comparator | Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an inactive fashion |
|
| Scaling and use of active Er,Cr:YSGG | Experimental | Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an active fashion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Er,Cr:YSGG laser | Device | Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Kang, DDS | Columbia University College of Dental Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University College of Dental Medicine | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Scaling and Use of 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 inactive fashion Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) Inactive Er,Cr:YSGG: Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant |
| FG001 | Scaling and Use of Active 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 Er,Cr:YSGG laser: Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Scaling and Use of 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 inactive fashion Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) Inactive Er,Cr:YSGG: Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analyzed 10 out of 16 subjects who completed the study in the control (inactive) group, and 13 out of 15 subjects who completed the study in the laser (active) group. | Posted | Mean | 95% Confidence Interval | mm | Baseline, 9 months | implants | implants |
|
Up to 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scaling and Use of 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 inactive fashion Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) Inactive Er,Cr:YSGG: Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip Y. Kang, DDS | Columbia University College of Dental Medicine | 212-342-5244 | pyk2104@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2022 | Jun 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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Double blind randomized clinical trial
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| Scaling | Procedure | Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) |
|
| Inactive Er,Cr:YSGG | Device | Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant |
|
| 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. | 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 | 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. | 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. | Baseline, 9 months |
| BG001 | Scaling and Use of Active 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 Er,Cr:YSGG laser: Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Implant Prosthesis | Number | implants |
|
| OG001 | Scaling and Use of Active 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 Er,Cr:YSGG laser: Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) |
|
|
| Secondary | 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. | Analyzed 10 out of 16 subjects who completed the study in the control (inactive) group, and 13 out of 15 subjects who completed the study in the laser (active) group. | Posted | Mean | 95% Confidence Interval | mm | Baseline, 9 months | impants | impants |
|
|
|
| Secondary | 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. | Analyzed 10 out of 16 subjects who completed the study in the control (inactive) group, and 13 out of 15 subjects who completed the study in the laser (active) group. | Posted | Mean | 95% Confidence Interval | percentage of bleeding | Baseline, 9 months | implants | implants |
|
|
|
| Secondary | Presence of Suppuration on Probing | Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic | Data was not collected. | Posted | 9 months |
|
|
| Secondary | 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. | Analyzed 10 out of 16 subjects who completed the study in the control (inactive) group, and 13 out of 15 subjects who completed the study in the laser (active) group. | Posted | Mean | 95% Confidence Interval | percentage of plaque | Baseline, 9 months | implants | implants |
|
|
|
| Secondary | 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. | Analyzed 10 out of 16 subjects who completed the study in the control (inactive) group, and 13 out of 15 subjects who completed the study in the laser (active) group. | Posted | Mean | 95% Confidence Interval | mm | Baseline, 9 months | implants | implants |
|
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Scaling and Use of Active 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 Er,Cr:YSGG laser: Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) | 0 | 13 | 0 | 13 | 0 | 13 |
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