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NCT Number: NCT07680491

Non-surgical Treatment of Peri-implant Pockets With H42

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, University of Seville

Seville, 41009, Spain

Location status: Recruiting

Location contact

Guillermo Machuca-Portillo, MD

CONTACT

[email protected]

954481128 ext. +34

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Pocket Probing Depth (PPD)

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

    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

  2. Plaque Index (PI)

    Time frame: At 1 month and 3 months in comparison with the baseline

    For each tooth, the four-point scale Silness and Löe Plaque Index is used (Score 0: Excellent; 3: poor)

  3. Degree of inflammation

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

    Not inflamed, mild inflamed, Moderately inflamed, Very inflamed

  4. NRS scale

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

    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)

  5. Absence of infection

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

    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.

Secondary outcomes

  1. Tissue assessment

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

    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

  2. Radiographic image (x-ray)

    Time frame: Baseline and 3 months follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Di Bona, PhD

CONTACT

[email protected]

32779983709 ext. +39

Marco Morroni, PhD

CONTACT

[email protected]

389 059 0480 ext. +39

Sponsors and collaborators

Lead sponsor

Bioteck S.p.A.

Industry

Collaborators

  • University of Seville

Registry information

Acronym: H42

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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