Trial Outcomes & Findings for Peri-implantitis Treatment: Clinical Results of Conventional Treatment vs. the Addition of Biolase (NCT NCT03544515)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Baseline, 9 months

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	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	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)
Overall Study STARTED	16	15
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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)
Overall Study Didn't complete study follow-up due to pandemic pause in research activity	4	2
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=16 Participants 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	Scaling and Use of Active Er,Cr:YSGG n=15 Participants 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)	Total n=31 Participants Total of all reporting groups
Age, Continuous	67.19 years STANDARD_DEVIATION 9.26 • n=16 Participants	62.53 years STANDARD_DEVIATION 7.12 • n=15 Participants	64.93 years STANDARD_DEVIATION 8.49 • n=31 Participants
Sex: Female, Male Female	4 Participants n=16 Participants	2 Participants n=15 Participants	6 Participants n=31 Participants
Sex: Female, Male Male	12 Participants n=16 Participants	13 Participants n=15 Participants	25 Participants n=31 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	15 participants n=15 Participants	31 participants n=31 Participants
Implant Prosthesis screw-retained	19 implants n=16 Participants	8 implants n=15 Participants	27 implants n=31 Participants
Implant Prosthesis cement-retained	41 implants n=16 Participants	20 implants n=15 Participants	61 implants n=31 Participants

PRIMARY outcome

Timeframe: Baseline, 9 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=26 implants 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	Scaling and Use of Active Er,Cr:YSGG n=38 implants 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)
Change in Probing Depth (PD)	-0.73 mm Interval -1.17 to 0.28	-1.36 mm Interval -1.96 to 0.77

SECONDARY outcome

Timeframe: Baseline, 9 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=26 impants 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	Scaling and Use of Active Er,Cr:YSGG n=38 impants 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)
Change in Radiographic Bone Loss Around the Implant	0.02 mm Interval -0.56 to 0.61	0.05 mm Interval -0.8 to 0.91

SECONDARY outcome

Timeframe: Baseline, 9 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=26 implants 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	Scaling and Use of Active Er,Cr:YSGG n=13 Participants 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)
Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)	-20 percentage of bleeding Interval -37.0 to -2.0	-36 percentage of bleeding Interval -61.0 to -1.0

SECONDARY outcome

Timeframe: 9 months

Population: Data was not collected.

Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 9 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=38 implants 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	Scaling and Use of Active Er,Cr:YSGG n=26 implants 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)
Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque	-30 percentage of plaque Interval -50.0 to -8.0	-29 percentage of plaque Interval -54.0 to -2.0

SECONDARY outcome

Timeframe: Baseline, 9 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Scaling and Use of Inactive Er,Cr:YSGG n=26 implants 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	Scaling and Use of Active Er,Cr:YSGG n=38 implants 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)
Mobility: Mean Change in the Clinical Attachment Level (CAL)	-1.2 mm Interval -1.97 to -0.36	-0.90 mm Interval -1.34 to -0.47

Adverse Events

Scaling and Use of Inactive Er,Cr:YSGG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Scaling and Use of Active Er,Cr:YSGG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Y. Kang, DDS

Columbia University College of Dental Medicine

Phone: 212-342-5244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place