Clinical trial NCT03127228: Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis
Official title: Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Laser
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Morita J USA
First posted: 2017-04-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

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.

Primary outcomes:
measure: Change in Periodontal Probing Depths (PD)
timeFrame: Baseline and 24 Week
measure: Change in Clinical Attachment Level (CAL)
timeFrame: Baseline and 24 Week
measure: Change in Bleeding on Probing (BOP)
timeFrame: Baseline and 24 Week
measure: Change in Radiographic Bone Fill (RBF)
timeFrame: Baseline and 24 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
name: Jeff (Chin-Wei) Wang, DDS, DMSc
role: PRINCIPAL_INVESTIGATOR
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