Non-surgical Treatment of Peri-implant Pockets With H42
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peri-implantitis. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Pocket Probing Depth (PPD) [Time frame: At 1 month and 3 months in comparison with the baseline value]
- Plaque Index (PI) [Time frame: At 1 month and 3 months in comparison with the baseline]
- Degree of inflammation [Time frame: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
- NRS scale [Time frame: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
- Absence of infection [Time frame: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
Secondary outcome measures (2)
- Tissue assessment [Time frame: Baseline and 7 days, at 14 days, at 21 days, at 1 month and 3 months of follow-up]
- Radiographic image (x-ray) [Time frame: Baseline and 3 months follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Spain · 1 center
- Faculty of Dentistry, University of Seville — Seville
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. PMID 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. PMID 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 Classificati PMID 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. PMID 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. PMID 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. PMID 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. PMID 29926489
Identifiers
NCT: NCT07680491 · 250423_H42_general