Laser Therapy Treatment of Peri-implantitis.

Phase 3

Withdrawn

• Conditions: Peri-implantitis

• Registration Number: NCT01972399
• Lead Sponsor: University of Michigan

Brief Summary

The primary objective of this study is to compare the clinical outcomes of using Er: YAG laser along with bone graft and barrier membrane to conventional mechanical debridement also with bone graft and barrier membrane in the treatment of peri-implantitis infections.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03
• Study Start: 2016-01
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients, 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.
• Patients having a minimum of 1 dental implant with peri-implantitis.
• The dental implant with peri-implantitis has ≥ 3 threads exposed or pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus).
• The implants are in function for at least 6 months
• No uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease.
• Only rough surface implant will be included in this study

Exclusion Criteria

• Long-term use of antibiotics > 2 weeks in the past two months
• No peri-implantitis treatment in the last 2 months
• Patients 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.
• Patients with a history of medically diagnosed oral cancer, bisphosphonate usage, 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 or quit smoking less than 6 months
• Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c >7)
• Patients with allergies known to affect one or more of the treatment provided in this study
• Polish surface implants
• Implants with trabecular surface

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perio Probing Depth	Change in probing depth from beginning of study to 6 months after intervention

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing	Change in bleeding on probing from beginning of study to 6 months after intervention

Trial Locations

Locations (1)

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