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OpenTrials
Completed

NCT Number: NCT03544515

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

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University College of Dental Medicine

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Biolase (Biolase, Inc)

Scaling

Procedure

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

Inactive Er,Cr:YSGG

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Biolase Inc

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2018
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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