Laser Therapy Treatment of Peri-implantitis.

Phase 3

Withdrawn

• Conditions: Peri-implantitis
• Interventions: Procedure: Mechanical debridement; Procedure: Laser

• 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• Status: WITHDRAWN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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical	Mechanical debridement	Mechanical debridement will be used to clean out the area around the diseased implant to try to regain bone.
Laser	Laser	A laser will be used to clean out the area around the diseased implant to try to regain bone.

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