Reconstructive Management of Peri-implantitis
Primary Purpose
Resolution of Pathologic Process
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)
Sponsored by
About this trial
This is an interventional treatment trial for Resolution of Pathologic Process
Eligibility Criteria
Inclusion Criteria:
- Non-smokers
- No use of antibiotics recently
- No metabolic disorder
- Infra-osseous or combined peri-implantitis defect
Exclusion Criteria:
- Smokers
- Pregnant
- Metabolic disorders that affect bone healing
- Supra-crestal defects
Sites / Locations
- Clinica CICOM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Resorbable cross-linked barrier membrane
No barrier membrane
Arm Description
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)
Bone graft will be solely packed in the peri-implantitis bone defect with no membrane to cover
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05282667
First Posted
September 12, 2021
Last Updated
November 7, 2022
Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
1. Study Identification
Unique Protocol Identification Number
NCT05282667
Brief Title
Reconstructive Management of Peri-implantitis
Official Title
Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 16, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resolution of Pathologic Process
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resorbable cross-linked barrier membrane
Arm Type
Experimental
Arm Description
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)
Arm Title
No barrier membrane
Arm Type
Experimental
Arm Description
Bone graft will be solely packed in the peri-implantitis bone defect with no membrane to cover
Intervention Type
Procedure
Intervention Name(s)
Reconstructive therapy of peri-implantitis by means of bone graft (and barrier membrane in the test group)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes in clinical parameters
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in Bone level
Description
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
Time Frame
12-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-smokers
No use of antibiotics recently
No metabolic disorder
Infra-osseous or combined peri-implantitis defect
Exclusion Criteria:
Smokers
Pregnant
Metabolic disorders that affect bone healing
Supra-crestal defects
Facility Information:
Facility Name
Clinica CICOM
City
Badajoz
ZIP/Postal Code
06011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
To publish once collected the data
Citations:
PubMed Identifier
32410379
Citation
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.
Results Reference
background
PubMed Identifier
33904175
Citation
Monje 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.
Results Reference
result
Learn more about this trial
Reconstructive Management of Peri-implantitis
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