Peri-implantitisH42NCT07680491
Non-surgical Treatment of Peri-implant Pockets With H42
An observational study of Peri-implantitis, run by Bioteck S.p.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Peri-implantitis
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2025to 30 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Di Bona, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, University of Seville
Seville, 41009
Guillermo Machuca-Portillo, MD, 954481128 ext. +34, gmachuca@us.es
About this study
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.
- Conditions
- Peri-implantitis
- Keywords
- H42
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| H42 treated group | 28 patients treated with ultrasonic treatment and manual curettes + H42® | |
| Control group | 28 patients only with ultrasonic treatment and manual curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1 month and 3 months in comparison with the baseline value
Plaque Index (PI)
For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor)
Measured: At 1 month and 3 months in comparison with the baseline
Degree of inflammation
Not inflamed, mild inflamed, Moderately inflamed, Very inflamed
Measured: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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)
Measured: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Absence of infection
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.
Measured: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
Secondary outcomes (2)
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
Measured: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up
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.
Measured: Baseline and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start3 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioteck S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Seville
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680491
- Sponsor's protocol ID
- 250423_H42_general
- Acronym
- H42
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.
PubMed 37271498Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Periodontol. 2018 Jun;89 Suppl 1:S267-S290. doi: 10.1002/JPER.16-0350.
PubMed 29926957Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
PubMed 29926955Rokaya D, Srimaneepong V, Wisitrasameewon W, Humagain M, Thunyakitpisal P. Peri-implantitis Update: Risk Indicators, Diagnosis, and Treatment. Eur J Dent. 2020 Oct;14(4):672-682. doi: 10.1055/s-0040-1715779. Epub 2020 Sep 3.
PubMed 32882741Robitaille N, Reed DN, Walters JD, Kumar PS. Periodontal and peri-implant diseases: identical or fraternal infections? Mol Oral Microbiol. 2016 Aug;31(4):285-301. doi: 10.1111/omi.12124. Epub 2015 Sep 15.
PubMed 26255984Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
PubMed 25495683Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.
PubMed 29926489