NCT03544515

Peri-implantitis Treatment: Clinical Results of Conventional Treatment vs. the Addition of Biolase

Completed NA Results posted Last updated 9 August 2024

What this trial tests

NA trial testing Er,Cr:YSGG laser in Peri-Implantitis in 32 participants. Completed in 15 August 2021.

Timeline

14 January 2019

Primary endpoint
2 August 2021

15 August 2021

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	14 January 2019
Primary completion	2 August 2021
Estimated completion	15 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Er,Cr:YSGG laser
• Scaling
• Inactive Er,Cr:YSGG

Conditions studied

• Peri-Implantitis — all drugs for Peri-Implantitis →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Probing Depth (PD) Primary · Baseline, 9 months

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.

Group	Value	95% CI
Scaling and Use of Inactive Er,Cr:YSGG	-0.73	-1.17 – 0.28
Scaling and Use of Active Er,Cr:YSGG	-1.36	-1.96 – 0.77

Change in Radiographic Bone Loss Around the Implant Secondary · Baseline, 9 months

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.

Group	Value	95% CI
Scaling and Use of Inactive Er,Cr:YSGG	0.02	-0.56 – 0.61
Scaling and Use of Active Er,Cr:YSGG	0.05	-0.80 – 0.91

Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP) Secondary · Baseline, 9 months

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.

Group	Value	95% CI
Scaling and Use of Inactive Er,Cr:YSGG	-20	-37 – -2
Scaling and Use of Active Er,Cr:YSGG	-36	-61 – -1

Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque Secondary · Baseline, 9 months

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.

Group	Value	95% CI
Scaling and Use of Inactive Er,Cr:YSGG	-30	-50 – -8
Scaling and Use of Active Er,Cr:YSGG	-29	-54 – -2

Mobility: Mean Change in the Clinical Attachment Level (CAL) Secondary · Baseline, 9 months

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.

Group	Value	95% CI
Scaling and Use of Inactive Er,Cr:YSGG	-1.2	-1.97 – -0.36
Scaling and Use of Active Er,Cr:YSGG	-0.90	-1.34 – -0.47

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.