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NCT Number: NCT06614426

Surgical Treatment of Peri-implantitis Defects

The aim of this study is to evaluate the efficacy of implant surface decontamination using electrolysis cleaning system. And to evaluate the adjunctive use of L-PRF in promoting soft tissue healing and long-term stability of the peri-implant marginal bone in the surgical treatment of peri-implantitis.

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Key information

Conditions

Peri Implantitis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Research design

  • Prospective, in which participants will be recruited and then followed up throughout a specified period of time.
  • Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.
  • Single-blinded as the outcome accessors will be blinded to the intervention.

Materials and Methods:

Patients attending Dubai Dental Hospital and requiring treatment of peri-implantitis will be invited to take part in this randomized controlled trial based on the following inclusion and exclusion criteria:

Inclusion criteria

  • Aged 18 or over.
  • Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
  • Screw retained implant crown.
  • Good compliance and commitment to attend follow-up review appointments.
  • Willing to provide informed consent.

Exclusion criteria

  • History of surgical therapy of peri-implantitis.
  • Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
  • Cement retained implant crown.
  • Systemic/local antibiotics during the previous 6 months.
  • Bone metabolic disease and/or taking medications that affect bone metabolism.
  • History of malignancy, radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Smokers

The study will be conducted following the ethical standards of the Declaration of Helsinki in 1975, as revised in 2013 and the CONSORT statement will be used as a guideline in reporting this study.

Randomization, allocation concealment and blinding:

The participants will be randomly allocated to three equally sized groups using computer-generated numbers:

Control group (C): Conventional open flap debridement Test group 1 (T1): Open flap debridement using (GalvoSurge® - Straumann) Test group 2 (T2): Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 or over.
  • Require treatment of peri-implantitis (defined as the presence of bleeding and/or suppuration on gentle probing, probing depths of ≥ 6 mm, presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling).
  • Screw retained implant crown.
  • Good compliance and commitment to attend follow-up review appointments.
  • Willing to provide informed consent.

Exclusion criteria

  • History of surgical therapy of peri-implantitis.
  • Peri-implant defects indicated for regenerative procedure (i.e. contained bony defect).
  • Cement retained implant crown.
  • Systemic/local antibiotics during the previous 6 months.
  • Bone metabolic disease and/or taking medications that affect bone metabolism.
  • History of malignancy, radiotherapy or chemotherapy.
  • Pregnant or lactating women.
  • Smokers

Treatment and study plan

Test group 1 (T1)

Procedure

Test group 1 (T1): Open flap debridement using electrolysis decontamination

Test group 2 (T2)

Procedure

Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application

Control group (C)

Procedure

Conventional open flap debridement

Primary outcomes

  1. Probing pocket depth

    Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

    • Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.

Secondary outcomes

  1. Presence or absence of plaque, bleeding on probing and suppuration

    Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

    Presence or absence of plaque, bleeding on probing and suppuration: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe

  2. Peri-implant marginal bone level

    Time frame: Baseline (prior to surgical intervention), 12 and 24 months

    • Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs.

  3. Peri-implant soft tissue level

    Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

    • Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.

  4. Peri-implant soft tissue thickness (Phenotype)

    Time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

    • Peri-implant soft tissue thickness (Phenotype): measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using an endodontic spreader at 3 points.

Study contacts

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

Abeer Hakam

CONTACT

[email protected]

3053353797

Sponsors and collaborators

Lead sponsor

Abeer Hakam

Other

Registry information

Official study title

The Efficacy of Electrolysis Decontamination with or Without Leukocyteplatelet Rich Fibrin (L-PRF) in the Surgical Treatment of Peri-implantitis Defects: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

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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