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OpenTrials
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NCT Number: NCT05615051

Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)

* Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes * Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.

The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica CICOM

Badajoz, 06011, Spain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion:

  • Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
  • All patients in age of 18 to 80
  • non-smokers
  • no presence of systemic disease or medication known to alter bone metabolism
  • partial or complete edentulous patients that have no active periodontal disease.

Exclusion criteria

  • pregnancy or lactation
  • history of or current smokers
  • uncontrolled medical conditions,
  • lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
  • advanced(A) peri-implantitis (>50% of the implant length).

Treatment and study plan

Surface decontamination procedure aiming at reconstructive therapy

Device

Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis

Other names: Hydrogen peroxide

Primary outcomes

  1. Resolution of the disease

    Time frame: 12 months

    No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss

Secondary outcomes

  1. Radiographic bone gain and clinical outcomes

    Time frame: 12 months

    Bone gain and changes in defect angle when compared to baseline radiographic features and evolution of clinical parameters compared to baseline data

Sponsors and collaborators

Lead sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Other

Registry information

Official study title

Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Nov 14, 2022
Registry last updated
Jun 8, 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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