PEMF Effects on Peri-implant Tissues in Adults with Peri-implantitis
This study aims to evaluate whether pulsed electromagnetic field therapy can improve bone formation and reduce probing depth in adults with peri-implantitis.
PEMF and Control/Sham
+ PEMF and without PEMF
Dental Deposits+4
+ Dental Plaque
+ Stomatognathic Diseases
Treatment Study
Summary
Study start date: February 1, 2022
Actual date on which the first participant was enrolled.This clinical trial is focused on the non-surgical treatment of peri-implantitis, a condition where inflammation occurs around dental implants, potentially leading to bone loss. The study investigates the effects of Pulsed Electromagnetic Field (PEMF) therapy on the tissues surrounding dental implants. Participants include adults aged 20 to 85 who show specific signs of peri-implantitis, such as bone loss and bleeding, but do not have other periodontal issues. This research is important because it could offer a less invasive treatment option for peri-implantitis, potentially improving dental implant care and outcomes for those affected by this condition. Participants in the study undergo a random allocation process to receive either PEMF therapy or a sham treatment. During the study, each patient receives two temporary implants, one with PEMF therapy and one without, in their jaw to support a temporary prosthesis. After eight weeks, these implants and the surrounding tissues are examined to assess the tissue response. This involves comparing the healing and health of the tissues with and without the PEMF treatment. Patients are made aware of the potential risks and benefits of participating, and they consent to the study before it begins. The trial is designed to be double-blind, meaning neither the participants nor the evaluators know who is receiving the active treatment, ensuring unbiased results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Bone formation * good systemic and oral health * sufficient native bone to place implants of 3.0 mm diameter and 10 mm length for the bone formation arm treatment of peri-implantitis * patients aged 18-85 years with evidence of peri-implant crestal bone loss greater than 3mm but not more than 5mm; * the presence of bleeding on probing or suppuration; * an implant pocket depth of 6-8 mm; * implants with an internal hex connection of 3.75-4.1mm diameter; * implant-supported restoration that could be removed and later refitted * patients who adhered to their scheduled periodontal maintenance visits. Exclusion Criteria: * patients consuming medications that might affect soft and hard tissue healing/health (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 * missing data in patient's files.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorGroup III
PlaceboGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location