Clinical Trial: Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Laser-Assisted Regenerative Surgical Therapy for Peri-implantitis: A Randomized Controlled Clinical Trial

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 Summary:

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


Sponsor: University of Michigan

Current Primary Outcome:

  • Periodontal Probing Depths (PD) [ Time Frame: Three years ]
    PD will be measured in millimeters.
  • Clinical Attachment Level (CAL) [ Time Frame: Three years ]
    CAL will be measured in millimeters.
  • Gingival Index (GI) [ Time Frame: Three years ]

    GI will be measured by a score of 0,1,2,3 Score 0: Normal Gingiva Score 1: Mild inflammation, slight change in color, slight edema, no bleeding on probing.

    Score 2: Moderate inflammation, redness, edema, glazing, bleeding on probing. Score 3: Severe inflammation, marked redness, edema, ulceration and tendency to spontaneous bleeding.

  • Bleeding on Probing (BOP) [ Time Frame: Three years ]
    BOP will be measured dichotomously as 0 or 1. Score 0=no. Score 1=yes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Radiographic bone fill (RBF) [ Time Frame: Three years ]
    Peri-implant bony defect change will be measured compared to baseline
  • Peri-implant crevicular fluid (PICF) microbiological and biomarker analysis [ Time Frame: Three years ]
    Bacterial and biomarker profiles will be assessed at selected time points
  • Post-op pain Assessment [ Time Frame: Three years ]
    Post-op pain assessment will be measured on a 11 points Numeric Rating Scale (11-NRS). The scale range is 0-10 with zero equal to no pain and 10 equal to serve pain.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: April 19, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2020
Last Updated: April 23, 2017
Last Verified: April 2017