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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03544515

Enrollment

Registered

2018-06-01

Start date

2019-01-14

Completion date

2021-08-15

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Keywords

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

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.

Interventions

DEVICEEr,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

PROCEDUREScaling

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

DEVICEInactive Er,Cr:YSGG

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Double blind randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona) Inactive Er,Cr:YSGG: Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant	16
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 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 Scaling: Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)	15
Total	31

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Didn't complete study follow-up due to pandemic pause in research activity	4	2
Overall Study	Lost to Follow-up	2	0

Baseline characteristics

Characteristic	Scaling and Use of Inactive Er,Cr:YSGG	Scaling and Use of Active Er,Cr:YSGG	Total
Age, Continuous	67.19 years STANDARD_DEVIATION 9.26	62.53 years STANDARD_DEVIATION 7.12	64.93 years STANDARD_DEVIATION 8.49
Implant Prosthesis cement-retained	41 implants	20 implants	61 implants
Implant Prosthesis screw-retained	19 implants	8 implants	27 implants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	16 participants	15 participants	31 participants
Sex: Female, Male Female	4 Participants	2 Participants	6 Participants
Sex: Female, Male Male	12 Participants	13 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 13
other Total, other adverse events	0 / 10	0 / 13
serious Total, serious adverse events	0 / 10	0 / 13

Outcome results

Primary

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.