Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel, H42 Medical Device (NCT07700628) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Periodontal and Peri-Implant Pockets With a Novel Collagen Hydrogel, H42 Medical Device
Italy52 participantsStarted 2022-06-06
Plain-language summary
A retrospective, observational, non-profit study designed to evaluate the use of the H42 medical device in patients with periodontitis or peri-implantitis. The study included adult subjects aged 25 to 65 years with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm and 1-5 defects, treated with H42® according to standard clinical practice.
The primary outcome involved comparing the periodontal parameters-Periodontal Pocket Depth (PPD), Plaque Index (PI), Clinical Attachment Level (CAL), and Sulcus Bleeding Index (SBI)-before the application of H42 (baseline) and at follow-up visits after 30 and 90 days.
The secondary outcomes, on the other hand, assessed soft tissue healing, pain levels via Numeric Rating Scale (NRS 0-10), recurrence of infection, and any unexpected side effects observed. These parameters were assessed at 7, 14, 21, 30, and 90 days after the use of H42.
Who can participate
Age range
25 Years – 65 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
. Adults aged 25 years ≤ age ≤ 65 years.
. Subjects with peri-implant or periodontal pockets with probing depths (PD) between 5 and 8 mm.
. Subjects with 1-5 defects.
. Subjects willing to provide signed informed consent to participate in the clinical study.
Exclusion criteria
. Use of aspirin and/or antiplatelet agents one week prior to treatment.
. Smokers (≥10 cigarettes per day).
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.
What they're measuring
1
Change from Baseline in Periodontal Pocket Depth (PPD) at 30 and 90 days
Timeframe: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
2
Change from Baseline in Plaque Index (PI) at 30 and 90 days
Timeframe: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
3
Change from Baseline in Clinical Attachment Level (CAL) at 30 and 90 days
Timeframe: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
4
Change from Baseline in Sulcus Bleeding Index (SBI) at 30 ad 90 days
Timeframe: Baseline before H42 treatment; 30 days and 90 days after H42 treatment.
. Use of concomitant treatments or procedures aimed at improving gum health within the last six months prior to enrollment in the clinical trial, such as treatments with HA gel, filler injections, or surgical procedures.
. Subjects with infectious diseases, including infection with the herpes simplex virus, active hepatitis, or the human immunodeficiency virus.
. Subjects who have undergone cosmetic dental surgery within the previous 12 months.