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Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
NA trial testing Standard mechanical debridement in Peri-Implantitis in 24 participants. Completed in 2 November 2018.
| Lead sponsor | University of Michigan |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 26 June 2017 |
| Primary completion | 2 November 2018 |
| Estimated completion | 2 November 2018 |
| Sites | 1 location across United States |
University of Michigan
Adults 18 to 85, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
| Group | Value | 95% CI |
|---|---|---|
| Standard Mechanical Debridement | 1.85 | ± 1.71 |
| Er:YAG Laser-assisted Debridement | 2.65 | ± 2.14 |
CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
| Group | Value | 95% CI |
|---|---|---|
| Standard Mechanical Debridement | 1.47 | ± 1.76 |
| Er:YAG Laser-assisted Debridement | 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.
| Group | Value | 95% CI |
|---|---|---|
| Standard Mechanical Debridement | -0.39 | ± 0.55 |
| Er:YAG Laser-assisted Debridement | -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.
| Group | Value | 95% CI |
|---|---|---|
| Standard Mechanical Debridement | 1.08 | ± 1.04 |
| Er:YAG Laser-assisted Debridement | 1.27 | ± 1.14 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Standard Mechanical Debrid… | Er:YAG Laser-assisted Debr… |
|---|---|---|---|
| Sinus Tract Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Tooth pain | General disorders | — | — |
| Flu | Infections and infestations | — | — |
| Jaw discomfort | General disorders | — | — |
| Broken filling | General disorders | — | — |
| Shoulder Pain | Injury, poisoning and procedural complications | — | — |
| Fistula | Infections and infestations | — | — |
| Ulcer on ear | Ear and labyrinth disorders | — | — |
| Residual suture | General disorders | — | — |
| Shingles | Immune system disorders | — | — |
| Crown off | General disorders | — | — |
| Type 2 Diabetes | Immune system disorders | — | — |
Data from ClinicalTrials.gov NCT03127228 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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