Surgical Treatment of Peri-implantitis Defects

September 25, 2024 updated by: Abeer Hakam

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (C): Conventional open flap debridement
Conventional open flap debridement
Procedure: Control group (C)
Conventional open flap debridement
Experimental: Test group 1 (T1): Open flap debridement using electrolysis decontamination
Open flap debridement using (GalvoSurge® - Straumann)
Procedure: Test group 1 (T1)
Test group 1 (T1): Open flap debridement using electrolysis decontamination
Experimental: Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF
Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application
Procedure: Test group 2 (T2)
Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
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.
Baseline (prior to surgical intervention), 12 and 24 months
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.
Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
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.
Baseline (prior to surgical intervention), 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abeer Hakam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBRU IRB-2024-563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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