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