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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Marco Morroni, PhD contact

0444 289366 ext. +39

m.morroni@bioteck.com

Anna Di Bona, PhD contact

a.dibona@bioteck.com

Spain1 site, 1 recruiting

  • Faculty of Dentistry, University of Seville

    Seville, 41009

    Guillermo Machuca-Portillo, MD, 954481128 ext. +34, gmachuca@us.es

    Recruiting

Other trials in Spain

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.

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 groups in NCT07680491
Study groupRoleWhat they receive
H42 treated group28 patients treated with ultrasonic treatment and manual curettes + H42®
Control group28 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.

  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

    Measured: At 1 month and 3 months in comparison with the baseline value

  2. 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

  3. 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

  4. 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

  5. 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)

  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

    Measured: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up

  2. 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.

  1. First posted2 Jul 2026
  2. Study start3 Dec 2025
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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 37271498

  • Schwarz 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 29926957

  • Berglundh 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 29926955

  • Rokaya 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 32882741

  • Robitaille 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 26255984

  • Derks 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 25495683

  • Caton 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

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-implantitis, run by Bioteck S.p.A. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marco Morroni, PhD (0444 289366 ext. +39, m.morroni@bioteck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pocket Probing Depth (PPD) (time frame: At 1 month and 3 months in comparison with the baseline value). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07680491, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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