Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

University of Michigan

Status

Completed

Conditions

Peri-Implantitis

Treatments

Device: Er:YAG laser-assisted debridement

Other: Standard mechanical debridement

Study type

Interventional

Funder types

Other

Identifiers

NCT03127228

HUM00124386

Details and patient eligibility

About

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.

Full 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

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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.