Back to resultsLaser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard mechanical debridement
Er:YAG laser-assisted debridement
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring Laser
Eligibility Criteria
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 Exclusion Criteria:
- The researcher believes that it is not the best interest of the subject to stay in the study
- If the subject becomes ineligible to participate based on the exclusion criteria
- If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
- If the subject does not follow study related instructions
- The study is suspended or canceled.
Sites / Locations
- University of Michigan School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard mechanical debridement
Er:YAG laser-assisted debridement
Arm Description
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.
Outcomes
Primary Outcome Measures
Change in Periodontal Probing Depths (PD)
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Change in Clinical Attachment Level (CAL)
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03127228
First Posted
April 19, 2017
Last Updated
October 31, 2019
Sponsor
University of Michigan
Collaborators
Morita J USA
1. Study Identification
Unique Protocol Identification Number
NCT03127228
Brief Title
Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Official Title
Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Morita J USA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard mechanical debridement
Arm Type
Other
Arm Description
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Arm Title
Er:YAG laser-assisted debridement
Arm Type
Experimental
Arm Description
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.
Intervention Type
Other
Intervention Name(s)
Standard mechanical debridement
Intervention Description
Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
Intervention Type
Device
Intervention Name(s)
Er:YAG laser-assisted debridement
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Periodontal Probing Depths (PD)
Description
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Time Frame
Baseline and 24 Week
Title
Change in Clinical Attachment Level (CAL)
Description
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Time Frame
Baseline and 24 Week
Title
Change in Bleeding on Probing (BOP)
Description
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
Title
Change in Radiographic Bone Fill (RBF)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria:
The researcher believes that it is not the best interest of the subject to stay in the study
If the subject becomes ineligible to participate based on the exclusion criteria
If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
If the subject does not follow study related instructions
The study is suspended or canceled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff (Chin-Wei) Wang, DDS, DMSc
Organizational Affiliation
Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
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