Non-surgical Treatment of Peri-implant Pockets With H42
ConditionPeri-implantitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorBioteck S.p.A.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult patients diagnosed with peri-implantitis and treated at the Department of Stomatology, Faculty of Dentistry, University of Seville, Spain. Participants are recruited from patients seeking care at the university dental clinic and are allocated to the study groups according to the study protocol and predefined inclusion and exclusion criteria. The study evaluates the adjunctive use of H42 hydrogel in the non-surgical treatment of peri-implantitis using a case-control design.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
56 Participants
are grouped into 2 trial groupsGroup A: H42 treated group
Group B: Control group
Trial outcomes
Primary outcomes
1
Pocket Probing Depth (PPD)
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
Time frame
At 1 month and 3 months in comparison with the baseline value2
Plaque Index (PI)
For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor)
Time frame
At 1 month and 3 months in comparison with the baseline3
Degree of inflammation
Not inflamed, mild inflamed, Moderately inflamed, Very inflamed
Time frame
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up4
NRS scale
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)
Time frame
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-upSecondary outcomes
1
Tissue assessment
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
Time frame
Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up2
Radiographic image (x-ray)
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.
Time frame
Baseline and 3 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bioteck S.p.A.
Lead sponsor
University of Seville
Collaborator
Source ClinicalTrials.gov