Non-surgical Treatment of Peri-implant Pockets With H42

NCT07680491 | Recruiting

• 1 other identifier: 250423_H42_general
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implantitis

Keywords

H42

Outcome Measures

Primary Outcomes (5)

• 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

  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)

  At 1 month and 3 months in comparison with the baseline

• Degree of inflammation

  Not inflamed, mild inflamed, Moderately inflamed, Very inflamed

  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)

  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.

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

Secondary Outcomes (2)

• Tissue assessment

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

• Radiographic image (x-ray)

  Baseline and 3 months follow-up

Study Arms (2)

H42 treated group

28 patients treated with ultrasonic treatment and manual curettes + H42®

Control group

28 patients only with ultrasonic treatment and manual curettes

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioteck S.p.A.: lead
• University of Seville: collaborator

Study Sites (1)

Faculty of Dentistry, University of Seville

Seville, 41009, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 37271498 BACKGROUND

• 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.

  PMID: 29926957 BACKGROUND

• 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.

  PMID: 29926955 BACKGROUND

• 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.

  PMID: 32882741 BACKGROUND

• 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.

  PMID: 26255984 BACKGROUND

• 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.

  PMID: 25495683 BACKGROUND

• 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.

  PMID: 29926489 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Marco Morroni, PhD

CONTACT

389 059 0480; m.morroni@bioteck.com

Anna Di Bona, PhD

CONTACT

32779983709; a.dibona@bioteck.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 2, 2026
• Study Start: December 3, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)