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

July 16, 2024 updated by: Philip Y. Kang, Columbia University

Treatment of Peri-implantitis: Clinical Comparison Between Conventional Treatment Versus Conventional Plus Biolase Laser Treatment as a Co-adjuvant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University College of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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
Procedure: Scaling
Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)
Device: Inactive Er,Cr:YSGG
Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant
Experimental: 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
Procedure: Scaling
Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)
Device: 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
Other Names:
  • Biolase (Biolase, Inc)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Depth (PD)
Time Frame: 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.
Baseline, 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Radiographic Bone Loss Around the Implant
Time Frame: 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.
Baseline, 9 months
Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)
Time Frame: 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.
Baseline, 9 months
Presence of Suppuration on Probing
Time Frame: 9 months
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
Time Frame: 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.
Baseline, 9 months
Mobility: Mean Change in the Clinical Attachment Level (CAL)
Time Frame: 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.
Baseline, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Biolase Inc

Investigators

  • Principal Investigator: Philip Kang, DDS, Columbia University College of Dental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

August 2, 2021

Study Completion (Actual)

August 15, 2021

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR8727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe