Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Other: Standard mechanical debridement

• Registration Number: NCT03127228
• Lead Sponsor: University of Michigan

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

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-25
• Study Start: 2017-06-26
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Status Verified: 2019-10
• Results First Submitted: 2019-10-12
• Results First Submitted QC: 2019-10-12
• Last Update Submitted: 2019-10-31
• Results First Posted: 2019-11-01
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard mechanical debridement	Standard mechanical debridement	Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with dental scalers.
Er:YAG laser-assisted debridement	Standard mechanical debridement	Debridement and surface detoxification of the implant surface and removal of the inflamed tissue with the aid of the laser treatment.

Primary Outcome Measures

Name	Time	Method
Change in Periodontal Probing Depths (PD)	Baseline and 24 Week	PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.
Change in Clinical Attachment Level (CAL)	Baseline and 24 Week	CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.
Change in Bleeding on Probing (BOP)	Baseline and 24 Week	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.
Change in Radiographic Bone Fill (RBF)	Baseline and 24 Week	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.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States