Trial Outcomes & Findings for Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis (NCT NCT03127228)
NCT ID: NCT03127228
Last Updated: 2019-11-15
Results Overview
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 24 Week
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Mechanical Debridement
n=12 Participants
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
|
Er:YAG Laser-assisted Debridement
n=12 Participants
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
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.41 years
STANDARD_DEVIATION 13.48 • n=12 Participants
|
66.41 years
STANDARD_DEVIATION 8.76 • n=12 Participants
|
64.91 years
STANDARD_DEVIATION 11.22 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
14 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeekPD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Outcome measures
| Measure |
Standard Mechanical Debridement
n=12 Implants
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
|
Er:YAG Laser-assisted Debridement
n=12 Implants
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
|
|---|---|---|
|
Change in Periodontal Probing Depths (PD)
|
1.85 millimeters
Standard Deviation 1.71
|
2.65 millimeters
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline and 24 WeekCAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Outcome measures
| Measure |
Standard Mechanical Debridement
n=12 Implants
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
|
Er:YAG Laser-assisted Debridement
n=12 Implants
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
|
|---|---|---|
|
Change in Clinical Attachment Level (CAL)
|
1.47 millimeters
Standard Deviation 1.76
|
1.90 millimeters
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: Baseline and 24 WeekBOP 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.
Outcome measures
| Measure |
Standard Mechanical Debridement
n=12 Implants
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
|
Er:YAG Laser-assisted Debridement
n=12 Implants
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
|
|---|---|---|
|
Change in Bleeding on Probing (BOP)
|
-0.39 percentage of sites with BOP
Standard Deviation 0.55
|
-0.31 percentage of sites with BOP
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Baseline and 24 WeekPeri-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.
Outcome measures
| Measure |
Standard Mechanical Debridement
n=12 Implants
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
|
Er:YAG Laser-assisted Debridement
n=12 Implants
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
|
|---|---|---|
|
Change in Radiographic Bone Fill (RBF)
|
1.08 Millimeters
Standard Deviation 1.04
|
1.27 Millimeters
Standard Deviation 1.14
|
Adverse Events
Standard Mechanical Debridement
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Er:YAG Laser-assisted Debridement
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Mechanical Debridement
n=12 participants at risk
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
|
Er:YAG Laser-assisted Debridement
n=12 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sinus Tract Infection
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
General disorders
Tooth pain
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Infections and infestations
Flu
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
General disorders
Jaw discomfort
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
General disorders
Broken filling
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Injury, poisoning and procedural complications
Shoulder Pain
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Infections and infestations
Fistula
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Ear and labyrinth disorders
Ulcer on ear
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
General disorders
Residual suture
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Immune system disorders
Shingles
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
General disorders
Crown off
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
|
Immune system disorders
Type 2 Diabetes
|
8.3%
1/12 • Number of events 1 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
0.00%
0/12 • 6 months
The methods for gathering adverse events included a medical and dental history review at each study visit and an oral exam at each study visit. In addition, participants self-reported any adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place