Peri-Implantitis
Conditions
Keywords
Laser
Brief summary
The purpose of the study is to evaluate if using Erbium-doped yttrium aluminium garnet laser, Erbium YAG laser (Er:YAG) laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects.
Detailed description
The purpose of the study is to evaluate if using Er:YAG laser could have adjunctive benefits to the conventional standard mechanical debridement to ablate the infected tissue around the dental implant and detoxify the contaminated implant surface for resolving peri-implant infection and enhance bone regeneration of peri-implant defects. This study involves one center and a double-blinded randomized controlled clinical trial is planned. Twenty-four adult patients in the need of surgical treatment due to peri-implantitis will be included. Six visits are needed for each patient including a 24 week follow-up visit. Specific Aim 1: To compare the clinical benefit of Er:YAG laser-assisted peri-implant defect debridement and surface detoxification with conventional mechanical debridement for regenerative therapy Specific Aim 2: To evaluate whether Er:YAG laser-assisted regenerative surgical therapy can decrease bacterial load and alter microbial profile Specific Aim 3: To analyze whether Er:YAG laser-assisted regenerative surgical therapy can impact the molecular profile of the peri-implant crevicular fluid (PICF) and the stability of the treatment
Interventions
OTHERStandard mechanical debridement
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
DEVICEEr:YAG laser-assisted debridement
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy
Sponsors
Morita J USA
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects, aged 18 - 85 years * Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases. * Subjects having a minimum of 1 dental implant with peri-implantitis. * Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus) * The implants are in function for at least 6 months * Only rough surface implant will be included in this study
Exclusion criteria
* Long-term use of antibiotics \> 2 weeks in the past two months * Obvious malpositioning of the dental implants * Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate) * Pregnant females or those planning to become pregnant * Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded * Mobility of dental implants * History of alcoholism or drug abuse * Current smokers * Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>8) * Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease Premature
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Periodontal Probing Depths (PD) | Baseline and 24 Week | PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks. |
| Change in Clinical Attachment Level (CAL) | Baseline and 24 Week | CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks. |
| Change in Bleeding on Probing (BOP) | Baseline and 24 Week | BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP. |
| Change in Radiographic Bone Fill (RBF) | Baseline and 24 Week | Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Mechanical Debridement Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy | 12 |
| Er:YAG Laser-assisted Debridement Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.
Standard mechanical debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
Er:YAG laser-assisted debridement: Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Er:YAG Laser-assisted Debridement | Total | Standard Mechanical Debridement |
|---|---|---|---|
| Age, Continuous | 66.41 years STANDARD_DEVIATION 8.76 | 64.91 years STANDARD_DEVIATION 11.22 | 63.41 years STANDARD_DEVIATION 13.48 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 6 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Change in Bleeding on Probing (BOP)
BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.
Time frame: Baseline and 24 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Mechanical Debridement | Change in Bleeding on Probing (BOP) | -0.39 percentage of sites with BOP | Standard Deviation 0.55 |
| Er:YAG Laser-assisted Debridement | Change in Bleeding on Probing (BOP) | -0.31 percentage of sites with BOP | Standard Deviation 0.62 |
Primary
Change in Clinical Attachment Level (CAL)
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Time frame: Baseline and 24 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Mechanical Debridement | Change in Clinical Attachment Level (CAL) | 1.47 millimeters | Standard Deviation 1.76 |
| Er:YAG Laser-assisted Debridement | Change in Clinical Attachment Level (CAL) | 1.90 millimeters | Standard Deviation 2.28 |
Primary
Change in Periodontal Probing Depths (PD)
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Time frame: Baseline and 24 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Mechanical Debridement | Change in Periodontal Probing Depths (PD) | 1.85 millimeters | Standard Deviation 1.71 |
| Er:YAG Laser-assisted Debridement | Change in Periodontal Probing Depths (PD) | 2.65 millimeters | Standard Deviation 2.14 |
Primary
Change in Radiographic Bone Fill (RBF)
Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.
Time frame: Baseline and 24 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Mechanical Debridement | Change in Radiographic Bone Fill (RBF) | 1.08 Millimeters | Standard Deviation 1.04 |
| Er:YAG Laser-assisted Debridement | Change in Radiographic Bone Fill (RBF) | 1.27 Millimeters | Standard Deviation 1.14 |