N/A
N=24
Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Peri-Implantitis
Bottom Line
View on ClinicalTrials.gov: NCT03127228 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Periodontal Probing Depths (PD) — 1.85; 2.65 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard mechanical debridement (Other); Er:YAG laser-assisted debridement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Periodontal Probing Depths (PD) |
1.85; 2.65 | — |
| PRIMARY Change in Clinical Attachment Level (CAL) |
1.47; 1.90 | — |
| PRIMARY Change in Bleeding on Probing (BOP) |
-0.39; -0.31 | — |
| PRIMARY Change in Radiographic Bone Fill (RBF) |
1.08; 1.27 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03127228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.