Peri-implantitis
Conditions
Keywords
H42
Brief summary
This prospective, observational study evaluates the efficacy and safety of H42 non-surgical treatment for peri-implant pockets. The trial involves 56 patients, with 28 subjects receiving the H42 treatment and 28 acting as a control group to monitor soft tissue healing and bone level changes. Clinical outcomes focus on Pocket Probing Depth (PPD) and Silness and Löe Plaque Index (PI) measured at baseline, 1 month, and 3 months. Gingival inflammation, pain intensity on a 0-10 NRS scale, and absence of infection are monitored at baseline, 7, 14, and 21 days, and at 1 and 3 months. Additionally, a five-point tissue assessment evaluates color, suppuration, granulation tissue, bleeding, and incision margins. Radiographic analysis at baseline and 3 months uses standardized periapical x-rays to measure bone level, intra-bony defect height, width, and angulation. Safety is assessed through the continuous registration of adverse events.
Interventions
None listed
Sponsors
Bioteck S.p.A.
University of Seville
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men or women with age ≥ 25 and ≤ 65 years. * Subjects affected by peri-implant pockets with probing depth (PD) in the range between 6 to 8 mm. * Each subject can have from 1 to 5 defects. * Subjects willing to provide signed informed consent to clinical investigation participation.
Exclusion criteria
* Use of aspirin and antiplatelet agents a week before treatment. * Subjects smokers ≥ 10 cigarettes per day. * Subjects presenting current or previous bleeding disorders. * Subjects taking or having indications for anticoagulant therapy. * Concomitant treatments or procedures to improve gum health over the last six months before the clinical investigation enrolment, such as HA gel treatments, injection of fillers, and surgery. * Subjects suffering from infectious diseases, including herpes simplex infection, active hepatitis, or human immunodeficiency virus. * Subjects with dental aesthetic surgery in the preceding 12 months before the clinical investigation enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index (PI) | At 1 month and 3 months in comparison with the baseline | For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor) |
| Degree of inflammation | Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up | Not inflamed, mild inflamed, Moderately inflamed, Very inflamed |
| Absence of infection | Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up | Clinical evaluation to assess the absence of infection, specifically defined as the absence of suppuration (pus formation), at the treated site as evaluated by the Investigator. |
| NRS scale | Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up | Numeric Rating Scale is a simple, reliable tool used to measure pain intensity on a scale from 0 to 10 (0: no pain; 10: maximum pain) |
| Pocket Probing Depth (PPD) | At 1 month and 3 months in comparison with the baseline value | The distance measured from the base of the pocket to the most apical point on the gingival margin, and it will be measured with an electronic Florida probe at controlled pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic image (x-ray) | Baseline and 3 months follow-up | Periapical radiographs were taken using the parallel long cone technique using a customized film-holder device and a bite block. - Bone level (BL): distance (mm) between the implant shoulder and the base of the defect. |
| Tissue assessment | Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up | Color, suppuration, granulation tissue, bleeding on palpation and incision margins on a five-point scale: 1 is very poor, 2 is poor, 3 is good, 4 is very good, and 5 is excellent |
Countries
Spain
Contacts
CONTACTMarco Morroni, PhD
CONTACTAnna Di Bona, PhD
Outcome results
None listed