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

NCT03544515 | Completed Results FDA Device

• 1 other identifier: AAAR8727
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis

Keywords

peri-implantitis; laser treatment; Biolase; Er,Cr:YSGG

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Radiographic Bone Loss Around the Implant

  Baseline, 9 months

• Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)

  Baseline, 9 months

• Presence of Suppuration on Probing

  9 months

• Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque

  Baseline, 9 months

• Mobility: Mean Change in the Clinical Attachment Level (CAL)

  Baseline, 9 months

Study Arms (2)

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

Procedure: Scaling; Device: Inactive Er,Cr:YSGG

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

Device: Er,Cr:YSGG laser; Procedure: Scaling

Interventions

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

Also known as: Biolase (Biolase, Inc)

Scaling and use of active Er,Cr:YSGG

Scaling PROCEDURE

Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)

Scaling and use of active Er,Cr:YSGG; Scaling and use of inactive Er,Cr:YSGG

Inactive Er,Cr:YSGG DEVICE

Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant

Scaling and use of inactive Er,Cr:YSGG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mobility of the implant
• Peri-implantitis treatment rendered in the last 3 months

Sponsors & Collaborators

• Columbia University: lead
• Biolase Inc: collaborator

Study Sites (1)

Columbia University College of Dental Medicine

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Results Point of Contact

• Title: Philip Y. Kang, DDS
• Organization: Columbia University College of Dental Medicine

pyk2104@cumc.columbia.edu

212-342-5244

Study Officials

• Philip Kang, DDS

  Columbia University College of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dental Medicine

Model Details: Double blind randomized clinical trial

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 1, 2018
• Study Start: January 14, 2019
• Primary Completion: August 2, 2021
• Study Completion: August 15, 2021
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Locations

US (1)