Soft Peri-implant Tissue Around Different Abutment Materials (NCT03459547) | Clinical Trial Compass
UnknownNot Applicable
Soft Peri-implant Tissue Around Different Abutment Materials
Italy10 participantsStarted 2021-09-06
Plain-language summary
Soft tissue attachment to the implant surface serves as a biological seal preventing the development of inflammatory periimplant diseases (i.e. peri-implant mucositis and peri-implantitis).It occurs in the presence of a biomaterial during healing of the surgical wound that might be influence by this foreign body. Myofibroblasts represent key players in the physiological reconstruction of connective tissue after injury.
This work will focus on the role of myofibroblasts during the early phases of the healing process in peri-implant tissues around four different abutment materials.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Absence of Systemic Diseases / Disorders
* Smoking ≤ 5 cigarettes per day
* Periodontally healthy or treated
* Full-mouth plaque score (FMPS) ≤ 15% at baseline
* Full-mouth bleeding score (FMBS) ≤ 15% at baseline
* Presence of edentulous space needing an all on four or all on six treatment with overdenture
* Width of the keratinized gingiva ≥ 2 at the level of the crest
Exclusion Criteria:
(I) • Pregnancy / lactation
* Use of systemic antibiotics in the last 3 months
* Use of systemic antibiotics as prophylaxis for endocarditis
* A chronically treated patient (i.e. 2 weeks or longer) with medicines known to affect periodontal tissues (e.g. phenytoin, calcium antagonists, cyclosporine, warfarin and non-steroidal anti-inflammatory drugs) the last month before starting the study
* Radiotherapy in the neck-head region
* HIV, TB, hepatitis or other infectious diseases
* Abuse with drugs or alcohol
* Smoked cigarettes\> 5 cigarettes per day
* Untreated periodontitis
* FMPS\> 15% at baseline
* FMBS\> 15% at baseline
* Implants with peri-implant history
* Width of keratinized tissue over crest \<2 mm
* Need for bone reconstruction around implants to be inserted
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.