Resolution of Pathologic ProcessNCT05282667
Reconstructive Management of Peri-implantitis
A study testing Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group) in people with Resolution of Pathologic Process, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Resolution of Pathologic Process
- What is being tested?
- Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 27 Mar 2019to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers
- No use of antibiotics recently
- No metabolic disorder
- Infra-osseous or combined peri-implantitis defect
Who cannot join
- Smokers
- Pregnant
- Metabolic disorders that affect bone healing
- Supra-crestal defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT
With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.
One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.
In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.
Read the detailed description
The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up
- Conditions
- Resolution of Pathologic Process
- Being tested
- Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)Procedure or surgery
A full-thickness flap was raised to ensure sufficient access. Debridement of granulation tissue was subsequently conducted using a "mini-five" curette (Hu-Friedy) and site-specific Gracey curettes (Hu-Friedy). The surgical approach was tailored to the clinical scenario. Specifically, resective therapy by means of implantoplasty was performed for supracrestal defects (Meisinger LLC, Nauss, Germany). Surface detoxification was performed with 3% hydrogen peroxide during 2 minutes and irrigation with 0.12% chlorhexidine. The intraosseous compartment was grafted using mineralized and demineralized bone graft (LifeNet Health, Virginia, USA). The graft was compartmentalized in the test group with a collagen porcine resorbable membrane (RTM, Cytoplast, California, USA) adapted to the defect morphology. Nylon 5.0 (Resorba Sutures, Osteogenics Biomedical, Lubbock, Texas) was used for suturing, ensuring primary wound closure
| Study group | Role | What they receive |
|---|---|---|
| Resorbable cross-linked barrier membrane | Experimental | Bone graft will be covered with a resorbable barrier membrane to exclude undesired cells from the area aimed at being regenerated (peri-implantitis bone defect) Receives: Procedure: Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group) |
| No barrier membrane | Experimental | Bone graft will be solely packed in the peri-implantitis bone defect with no membrane to cover Receives: Procedure: Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical parameters
Number of patients where the disease was resolved. At implant level the changes in bleeding on probing and changes in probing pocket depths will be recorded as well
Measured: 12 months
Secondary outcomes (1)
Changes in Bone level
Change in Bone level measured in mm from x-rays obtained from the comparative between baseline bone level and bone level determined at 12-month follow-up
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start27 Mar 2019
- Primary completion15 Nov 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Resolution of Pathologic ProcessStudies 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
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282667
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To publish once collected the data
Publications
Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Epub 2020 May 14.
PubMed 32410379Monje A, Pons R, Amerio E, Wang HL, Nart J. Resolution of peri-implantitis by means of implantoplasty as adjunct to surgical therapy: A retrospective study. J Periodontol. 2022 Jan;93(1):110-122. doi: 10.1002/JPER.21-0103. Epub 2021 May 15.
PubMed 33904175Monje A, Pons R, Vilarrasa J, Nart J, Wang HL. Significance of barrier membrane on the reconstructive therapy of peri-implantitis: A randomized controlled trial. J Periodontol. 2023 Mar;94(3):323-335. doi: 10.1002/JPER.22-0511. Epub 2022 Dec 12.
PubMed 36399349
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT
- ClinicalTrials.gov ID
- NCT05282667
- Acronym / sponsor ID
- 1
- Conditions
- Resolution of Pathologic Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 16 Mar 2022 (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.
With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.
One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.
In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.
Detailed description
The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Resorbable cross-linked barrier membrane | Experimental | Procedure: Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)Bone graft will be covered with a resorbable barrier membrane to exclude undesired cells from the area aimed at being regenerated (peri-implantitis bone defect) |
| No barrier membrane | Experimental | Procedure: Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)Bone graft will be solely packed in the peri-implantitis bone defect with no membrane to cover |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smokers
- No use of antibiotics recently
- No metabolic disorder
- Infra-osseous or combined peri-implantitis defect
Key exclusion criteria (4 listed)
- Smokers
- Pregnant
- Metabolic disorders that affect bone healing
- Supra-crestal defects
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 |
|---|---|---|
| Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)A full-thickness flap was raised to ensure sufficient access. Debridement of granulation tissue was subsequently conducted using a "mini-five" curette (Hu-Friedy) and site-specific Gracey curettes (Hu-Friedy). The surgical approach was tailored to the clinical scenario. Specifically, resective therapy by means of implantoplasty was performed for supracrestal defects (Meisinger LLC, Nauss, Germany). Surface detoxification was performed with 3% hydrogen peroxide during 2 minutes and irrigation with 0.12% chlorhexidine. The intraosseous compartment was grafted using mineralized and demineralized bone graft (LifeNet Health, Virginia, USA). The graft was compartmentalized in the test group with a collagen porcine resorbable membrane (RTM, Cytoplast, California, USA) adapted to the defect morphology. Nylon 5.0 (Resorba Sutures, Osteogenics Biomedical, Lubbock, Texas) was used for suturing, ensuring primary wound closure | Procedure or surgery | No barrier membrane, Resorbable cross-linked barrier membrane |
Primary outcome
Changes in clinical parameters
Time frame: 12 months
Number of patients where the disease was resolved. At implant level the changes in bleeding on probing and changes in probing pocket depths will be recorded as well
1 secondary outcome
Changes in Bone level
Time frame: 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 32410379Monje A, Pons R, Roccuzzo A, Salvi GE, Nart J. Reconstructive therapy for the management of peri-implantitis via submerged guided bone regeneration: A prospective case series. Clin Implant Dent Relat Res. 2020 Jun;22(3):342-350. doi: 10.1111/cid.12913. Epub 2020 May 14.
- Results publication: PubMed 33904175Monje A, Pons R, Amerio E, Wang HL, Nart J. Resolution of peri-implantitis by means of implantoplasty as adjunct to surgical therapy: A retrospective study. J Periodontol. 2022 Jan;93(1):110-122. doi: 10.1002/JPER.21-0103. Epub 2021 May 15.
- Derived from this study: PubMed 36399349Monje A, Pons R, Vilarrasa J, Nart J, Wang HL. Significance of barrier membrane on the reconstructive therapy of peri-implantitis: A randomized controlled trial. J Periodontol. 2023 Mar;94(3):323-335. doi: 10.1002/JPER.22-0511. Epub 2022 Dec 12.
- Individual participant dataSharing planned: Undecided. To publish once collected the data
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group) in people with Resolution of Pathologic Process, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clinical parameters (time frame: 12 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 NCT05282667, which also lists 3 linked publications.
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 5 Dec 2024.