Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516523
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Impact of Pulsed Electromagnetic Field PEMF on Human Peri-implant Tissues
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Pulsed Electromagnetic Field PEMF on Human Peri-implant Tissues Clinical Proteomic Profile and Histological Analysis of a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulsed Electromagnetic field PEMF has been shown to heighten bone regeneration and wound healing in various clinical areas including dentistry In Oral implantology PEMF stimulation may enhance peri-implant bone formation and secondary stability and modulate the peri-implant microbiome This randomized controlled study will evaluate
1 the impact of PEMF around interim additive manufacturing AM implants immediately loaded and retrieved from human jaws after 60 days
2 the effect of PEMF on diseased dental implants using non-surgical therapy
1 the impact of PEMF around interim additive manufacturing AM implants immediately loaded and retrieved from human jaws after 60 days
2 the effect of PEMF on diseased dental implants using non-surgical therapy
Detailed Description:
Non-surgical treatment of peri-implantitisThis is a prospective double-blind randomized sham-controlled pilot study of a 3-month duration as shown in the study flow chart Figure 1 The data are reported according to the Consolidated Standards of Reporting Trials CONSORT guidelines Treatment allocation was by block randomization with a block size of four Both patients and evaluators were blind to whether the MED device was active or not
Patients who were diagnosed with peri-implantitis and fit the inclusion criteria were identified from the records The inclusion criteria were patients aged 20-85 years with evidence of peri-implant crestal bone loss greater than 3mm but not more than 5mm presence of bleeding on probing or suppuration an implant pocket depth of 6-8 mm implants with an internal hex connection of 375-41mm diameter implant-supported restoration that could be removed and later refitted and patients who adhered to their scheduled periodontal maintenance visits All patients in the study were under strict periodontal maintenance with no residual pockets at other sites at the time of diagnosis Furthermore all patients included in the study had signed an informed consent form
Exclusion criteria were identified based on patient records and included patients consuming medications that might affect soft and hard tissue healinghealth such as calcium channel blockers immunosuppressive and anticonvulsive medications patients currently taking systemic antibiotics chronic use of nonsteroidal anti-inflammatory drugs NSAIDs on a long-term basis excluding low dose aspirin presence of a pacemaker patients with periodontal disease cigarette smoking of more than 10 cigarettes a day and missing data in patients files
Bone formationThe present study will be designed as a randomized controlled investigation reporting on immediately loaded transitional transmucosal implants placed in the human posterior jaws and retrieved after 60 days This study aims to compare the early peri-implant tissues response to implants with or without PEMF activation when placed in the human posterior jaws and subjected to immediate loading protocol During a routine surgical procedure for the placement of conventional implants each enrolled patient also will receive two transitional transmucosal implants test-with and control-without PEMF which were inserted in the posterior area of the jaws mandible and maxilla according to a randomization process The transitional implants 30 mm x 10mm will be placed to support an interim prosthesis until healing of the conventional implants After 8 weeks during the second-stage surgery to uncover the conventional implants all transitional implants and surrounding tissues will be retrieved for evaluation This protocol was elaborated according to the Standard Protocol Items Recommendations for Interventional Studies SPIRIT protocol All eligible volunteers will be informed about the nature potential risks and benefits of participating in this study and will sign a free and informed consent term
Patients who were diagnosed with peri-implantitis and fit the inclusion criteria were identified from the records The inclusion criteria were patients aged 20-85 years with evidence of peri-implant crestal bone loss greater than 3mm but not more than 5mm presence of bleeding on probing or suppuration an implant pocket depth of 6-8 mm implants with an internal hex connection of 375-41mm diameter implant-supported restoration that could be removed and later refitted and patients who adhered to their scheduled periodontal maintenance visits All patients in the study were under strict periodontal maintenance with no residual pockets at other sites at the time of diagnosis Furthermore all patients included in the study had signed an informed consent form
Exclusion criteria were identified based on patient records and included patients consuming medications that might affect soft and hard tissue healinghealth such as calcium channel blockers immunosuppressive and anticonvulsive medications patients currently taking systemic antibiotics chronic use of nonsteroidal anti-inflammatory drugs NSAIDs on a long-term basis excluding low dose aspirin presence of a pacemaker patients with periodontal disease cigarette smoking of more than 10 cigarettes a day and missing data in patients files
Bone formationThe present study will be designed as a randomized controlled investigation reporting on immediately loaded transitional transmucosal implants placed in the human posterior jaws and retrieved after 60 days This study aims to compare the early peri-implant tissues response to implants with or without PEMF activation when placed in the human posterior jaws and subjected to immediate loading protocol During a routine surgical procedure for the placement of conventional implants each enrolled patient also will receive two transitional transmucosal implants test-with and control-without PEMF which were inserted in the posterior area of the jaws mandible and maxilla according to a randomization process The transitional implants 30 mm x 10mm will be placed to support an interim prosthesis until healing of the conventional implants After 8 weeks during the second-stage surgery to uncover the conventional implants all transitional implants and surrounding tissues will be retrieved for evaluation This protocol was elaborated according to the Standard Protocol Items Recommendations for Interventional Studies SPIRIT protocol All eligible volunteers will be informed about the nature potential risks and benefits of participating in this study and will sign a free and informed consent term
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None