BridgeMD
New treatment option for Peri Implant Mucositis
Official title Randomized, Controlled, Exploratory Study on the Treatment of Dental Implants Using the AmbiJet System for Peri-implantitis and Peri-implant Mucositis
ClinicalTrials.gov ID: NCT07722715
What this study is testing
- What it's testing
- Inflammation of the tissue surrounding a dental implant (peri-implantitis or peri-implant mucositis) can lead to implant loss in advanced stages. The AmbiJet system utilizes cold atmospheric plasma (CAP), a physical procedure with a strong antibacterial effect.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- General criteria:
- Men or women aged \>= 18 and \<= 65 years.
- For women of childbearing age: a form of contraception recognized by conventional medicine during the study.
- Written consent has been obtained from each patient for the study. Dental criteria:
- Current X-ray of the implant region available (\<= 6 months prior to first treatment).
You likely can't join if
- General criteria:
- Known allergies to materials used in the study (gold, copper, polyimide).
- Diabetes (type I or type II), vasculitis, osteoporosis, osteomalacia.
- Smokers (\>1 cigarette/week).
- Use of medications to modulate bone metabolism (e.g., bisphosphonates).
- Eating disorders such as bulimia or anorexia nervosa.
See the full eligibility criteria
- General criteria:
- Men or women aged \>= 18 and \<= 65 years.
- For women of childbearing age: a form of contraception recognized by conventional medicine during the study.
- Written consent has been obtained from each patient for the study. Dental criteria:
- Current X-ray of the implant region available (\<= 6 months prior to first treatment).
- One to five implants with bone loss from the start of the part of the implant intended for osseointegration (X-ray findings).
- Bleeding and/or suppuration after or without probing at the implant in question (peri-implant mucositis/peri-implantitis).
- Clinical signs of inflammation (swelling, redness, soft tissue) on the implant in question (peri-implant mucositis/peri-implantitis).
- Average oral hygiene (i.e., brushing teeth at least twice a day).
- General criteria:
- Known allergies to materials used in the study (gold, copper, polyimide).
- Diabetes (type I or type II), vasculitis, osteoporosis, osteomalacia.
- Smokers (\>1 cigarette/week).
- Use of medications to modulate bone metabolism (e.g., bisphosphonates).
- Eating disorders such as bulimia or anorexia nervosa.
- Use of antibiotics within the last 2 months prior to the start of the study.
- Application of local antibiotics in the oral cavity within the last 2 months prior to the start of the study.
- Use of antimicrobial mouthwashes within the last month before the start of the study.
- Anti-inflammatory medication within the last month before the start of the study.
- Pregnancy or breastfeeding.
- Alcoholism or drug abuse.
- Wound healing disorders.
- Immunosuppression.
- Condition following insertion of an electrical, electrically active, or electronic implant. Dental criteria:
- An implant with bone loss \>6 mm from the start of the part of the implant intended for osseointegration (X-ray findings) (peri-implantitis).
- Pathological changes in the oral mucosa or gingiva, such as oral lichen planus, chronic recurrent aphthae, melanotic macula, precancerous lesions (e.g., leukoplakia), melanomas.
- Use of medically unacceptable types of treatment, therapies, or substances (off-label use of treatments for peri-implant mucositis or peri-implantitis).
The study team makes the final eligibility decision.
Where it's taking place
- Romny, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Romny, Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.