Peri ImplantitisNCT06614426
Surgical Treatment of Peri-implantitis Defects
A study testing Test group 1 (T1) and Test group 2 (T2) in people with Peri Implantitis, run by Abeer Hakam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri Implantitis
- What is being tested?
- Test group 1 (T1) and Test group 2 (T2)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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
- Conditions
- Peri Implantitis
- Being tested
- Test group 1 (T1), Test group 2 (T2), Control group (C)
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group 1 (T1)Procedure or surgery
Test group 1 (T1): Open flap debridement using electrolysis decontamination
Test group 2 (T2)Procedure or surgery
Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application
Control group (C)Procedure or surgery
Conventional open flap debridement
| Study group | Role | What they receive |
|---|---|---|
| Control group (C): Conventional open flap debridement | Active comparator | Conventional open flap debridement Receives: Procedure: Control group (C) |
| Test group 1 (T1): Open flap debridement using electrolysis decontamination | Experimental | Open flap debridement using (GalvoSurge® - Straumann) Receives: 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 Receives: Procedure: Test group 2 (T2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
- Probing pocket depth: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
Measured: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Secondary outcomes (4)
Presence or absence of plaque, bleeding on probing and suppuration
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
Measured: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Peri-implant marginal bone level
- Peri-implant marginal bone level: measured at baseline (prior to surgical intervention), 12 and 24 months using standardized peri-apical radiographs.
Measured: Baseline (prior to surgical intervention), 12 and 24 months
Peri-implant soft tissue level
- Peri-implant soft tissue level: measured at baseline (prior to surgical intervention), 3, 6, 12 and 24 months using a manual periodontal probe.
Measured: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Peri-implant soft tissue thickness (Phenotype)
- 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.
Measured: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abeer Hakam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abeer Hakam, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614426
- Sponsor's protocol ID
- MBRU IRB-2024-563
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25909530
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06614426
- Acronym / sponsor ID
- MBRU IRB-2024-563
- Conditions
- Peri Implantitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Abeer HakamUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (C): Conventional open flap debridement | Active comparator | Procedure: Control group (C)Conventional open flap debridement |
| Test group 1 (T1): Open flap debridement using electrolysis decontamination | Experimental | Procedure: Test group 1 (T1)Open flap debridement using (GalvoSurge® - Straumann) |
| Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF | Experimental | Procedure: Test group 2 (T2)Open flap debridement using (GalvoSurge® - Straumann) combined with L-PRF application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test group 1 (T1)Test group 1 (T1): Open flap debridement using electrolysis decontamination | Procedure or surgery | Test group 1 (T1): Open flap debridement using electrolysis decontamination |
| Test group 2 (T2)Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF application | Procedure or surgery | Test group 2 (T2): Open flap debridement using electrolysis decontamination combined with L-PRF |
| Control group (C)Conventional open flap debridement | Procedure or surgery | Control group (C): Conventional open flap debridement |
Primary outcome
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.
4 secondary outcomes
Presence or absence of plaque, bleeding on probing and suppuration
Time frame: 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 soft tissue level
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 25909530Hamzacebi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Test group 1 (T1) and Test group 2 (T2) in people with Peri Implantitis, run by Abeer Hakam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer Hakam (3053353797, abeer.hakam@dubaihealth.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: Baseline (prior to surgical intervention), 3, 6, 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.