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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings