Laser Therapy Treatment of Peri-implantitis.

Peri-implantitis Clinical Trial

Official title:

Influence of Laser Therapy Upon Surgical Treatment of Peri-implantitis Lesions.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01972399
• Other study ID #: HUM00077816
• Status: Withdrawn
• Phase: Phase 3
• First received: October 7, 2013
• Last updated: April 1, 2015
• Start date: January 2016

Study information

• Verified date: April 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Procedure:
• Laser
This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
• Mechanical debridement
This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perio Probing Depth		Change in probing depth from beginning of study to 6 months after intervention	No
Secondary	Bleeding on Probing		Change in bleeding on probing from beginning of study to 6 months after intervention	No