An interventional study of Standard mechanical debridement and Er:YAG laser-assisted debridement in Peri-Implantitis, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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
313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 191 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
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Exclusion Criteria:
Premature Exclusion Criteria:
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Other: Standard mechanical debridement
Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.
Other: Standard mechanical debridement · Device: Er:YAG laser-assisted 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
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
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
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
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
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
| Milestone | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
| millimeters | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Change in Periodontal Probing Depths (PD) | 1.85 ± 1.71 | 2.65 ± 2.14 |
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
| millimeters | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Change in Clinical Attachment Level (CAL) | 1.47 ± 1.76 | 1.90 ± 2.28 |
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.
| percentage of sites with BOP | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Change in Bleeding on Probing (BOP) | -0.39 ± 0.55 | -0.31 ± 0.62 |
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.
| Millimeters | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Change in Radiographic Bone Fill (RBF) | 1.08 ± 1.04 | 1.27 ± 1.14 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Mechanical Debridement | 0/12 (0%) | 0/12 (0%) | 6/12 (50%) |
| Er:YAG Laser-assisted Debridement | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement |
|---|---|---|
| Sinus Tract InfectionRespiratory, thoracic and mediastinal disorders | 1/12 | 0/12 |
| Tooth painGeneral disorders | 1/12 | 0/12 |
| FluInfections and infestations | 1/12 | 0/12 |
| Jaw discomfortGeneral disorders | 1/12 | 0/12 |
| Broken fillingGeneral disorders | 0/12 | 1/12 |
| Shoulder PainInjury, poisoning and procedural complications | 1/12 | 0/12 |
| FistulaInfections and infestations | 1/12 | 0/12 |
| Ulcer on earEar and labyrinth disorders | 1/12 | 0/12 |
| Residual sutureGeneral disorders | 0/12 | 1/12 |
| ShinglesImmune system disorders | 0/12 | 1/12 |
| Age, Continuous(years) | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement | Total |
|---|---|---|---|
| Mean | 63.41 ± 13.48 | 66.41 ± 8.76 | 64.91 ± 11.22 |
| Sex: Female, Male(Participants) | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 7 | 7 | 14 |
| Race and Ethnicity Not Collected(Participants) | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard Mechanical Debridement | Er:YAG Laser-assisted Debridement | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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