NCT06614426

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

September 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

2.1 years

First QC Date

September 18, 2024

Last Update Submit

September 25, 2024

Conditions

Peri Implantitis

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

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

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

Secondary Outcomes (4)

  • Presence or absence of plaque, bleeding on probing and suppuration

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

  • Peri-implant marginal bone level

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

  • Peri-implant soft tissue level

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

  • Peri-implant soft tissue thickness (Phenotype)

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

Study Arms (3)

Control group (C): Conventional open flap debridement

ACTIVE COMPARATOR

Conventional open flap debridement

Procedure: Control group (C)

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

EXPERIMENTAL

Open flap debridement using (GalvoSurge® - Straumann)

Procedure: Test group 1 (T1)

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

EXPERIMENTAL

Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application

Procedure: Test group 2 (T2)

Interventions

Test group 1 (T1)PROCEDURE

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

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

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

Conventional open flap debridement

Control group (C): Conventional open flap debridement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861.

    PMID: 25909530BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Abeer Hakam

CONTACT

3053353797abeer.hakam@dubaihealth.ac.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 26, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

September 26, 2024

Record last verified: 2024-09