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

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Procedure: Scaling

• Registration Number: NCT03544515
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-01
• Study Start: 2019-01-14
• Primary Completion: 2021-08-02
• Study Completion: 2021-08-15
• Results First Submitted: 2022-06-17
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-16
• Results First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and use of inactive Er,Cr:YSGG	Scaling	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	Scaling	Scaling and debridement with hand scalers and ultrasonic unit together with the application of the Er,Cr:YSGG laser in an active fashion

Primary Outcome Measures

Name	Time	Method
Change in Probing Depth (PD)	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Percent of Implants That Presented Bleeding on Probing (BoP)	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.
Plaque Index (PI): Mean Change in Percent of Implants That Contained Plaque	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.
Change in Radiographic Bone Loss Around the Implant	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.
Presence of Suppuration on Probing	9 months	Recorded at 6 sites per implant (mesio-buccal and lingual, mid-buccal and lingual, disto-buccal and lingual). Dichotomic
Mobility: Mean Change in the Clinical Attachment Level (CAL)	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.

Trial Locations

Locations (1)

Columbia University College of Dental Medicine; 🇺🇸 New York, New York, United States