Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin (RAS)
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bone substitute; NanoBone®
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring dental implant, peri-implantitis, surgical treatment
Eligibility Criteria
Inclusion Criteria:
- age > 18 years,
- having at least one implant demonstrating bone defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration, implants had to be in function for >12 months,
- no implant mobility and no evidence of occlusal overload,
- no evidence of occlusal overload
- presence of at least 2 mm of keratinized attached mucosa .
Exclusion Criteria:
- serious systemic diseases, medications or conditions that would contraindicate periodontal surgery and compromise wound healing,
- history of taking systemic antibiotic during the past 3 months,
- smoking,
- pregnant or lactating females,
- implants previously augmented with bone substitute or placed in grafted bone,
- implants previously treated for peri-implantitis,
- a mobile implant.
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
bone substitute; NanoBone® (group 1, control group)
simvastatin + NanoBone (group 2, test group)
Arm Description
a synthetic bone substitute consisting of nanocrystalline hydroxyapatite and silica fabricated in a sol-gel process.
medications used to treat hypercholesterolemia
Outcomes
Primary Outcome Measures
Clinical attachment level (CAL)
Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession
Secondary Outcome Measures
probing pocket depth
measured as the distance from the mucosal margin to the base of the deepest pocket of the implant
plaque index (PI)
marked with a score from 0 to 3. Grade 0: no plaque; Grade 1: plaques could be found on the surface of the implant after scratching with the probe tip gently; Grade 2: plaque could be seen by the naked eye; and Grade 3: a large amount of plaques could be seen
Bleeding on probing (BoP)
modified sulcus bleeding index (mSBI) . This index scores the bleeding on a zero to three scale, where 0: no bleeding, 1: isolated bleeding spots, 2: blood forms a confluent red line and 3: heavy or profuse bleeding.
Mucosal recession (MR)
measured as the distance from the mucosal margin and the implant abutment interface
The change in bone level (BL)
the distance (mm) between the implant shoulder and the bottom of the defect
Full Information
NCT ID
NCT04559841
First Posted
September 7, 2020
Last Updated
September 16, 2020
Sponsor
Reham Lotfy Aggour
Collaborators
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT04559841
Brief Title
Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin
Acronym
RAS
Official Title
Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin: A 6-month Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reham Lotfy Aggour
Collaborators
October 6 University
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
The aim of this study was to evaluate the effect of using a synthetic bone substitute with or without simvastatin on regenerative surgical treatment of bone defects associated with peri-implantitis in a 6- months randomized controlled clinical trial.
A total of 30 patients diagnosed with peri-implantitis were randomly assigned to one of two surgical treatment groups (group I: synthetic bone substitute (NanoBone), group II: NanoBone with simvastatin). Clinical measurements included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), modified sulcus bleeding index (mSBI) and mucosal recession (MR). Radiographic bone fill was evaluated at baseline and after 6- months.
Detailed Description
The study was designed as a prospective single-center, parallel group, 6 month randomized clinical trial evaluating the effect of a bone substitute; NanoBone® (Artoss GmbH, Rostock, Germany) (group 1, control group) compared to the same bone substitute with simvastatin (Corvast 80 mg, Egyphar, Egypt) (group 2, test group) for RST of peri-implantitis. A total of 30 patients suffering from peri-implantitis who needed regenerative treatment of at least one peri-implant bone defect were selected and only one implant per patient (the most severe) was evaluated in the treatment groups. The criteria for diagnosing peri-implantitis is based on the consensus report of the eighth European Workshop on Periodontology [34] ; the presence of a peri-implant marginal bone loss ≥2 mm based on baseline periapical radiographs after delivery of the final restoration and bleeding on probing (BOP) and/or suppuration with or without concomitant deepening of peri-implant pockets.
Clinical and radiographic evaluation were conducted at baseline and 6 months postoperatively. Grouping was done using a random number table generated by a third party. They were numbered according to the order of enrolment and assigned to group I or group II. The grouping results were sealed in an opaque envelope and kept by an independent third party. For each patient, cards opened immediately before the surgical procedures. Treatment assignment in each patient was registered by the clinician who assisted in the operations and kept concealed until the completion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
dental implant, peri-implantitis, surgical treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-center, parallel group, 6 month randomized clinical trial
Masking
Outcomes Assessor
Masking Description
A single examiner blinded to the treatment assignment was responsible for evaluating the clinical parameters
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bone substitute; NanoBone® (group 1, control group)
Arm Type
Active Comparator
Arm Description
a synthetic bone substitute consisting of nanocrystalline hydroxyapatite and silica fabricated in a sol-gel process.
Arm Title
simvastatin + NanoBone (group 2, test group)
Arm Type
Experimental
Arm Description
medications used to treat hypercholesterolemia
Intervention Type
Other
Intervention Name(s)
bone substitute; NanoBone®
Other Intervention Name(s)
simvastatin
Intervention Description
surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession
Time Frame
6 months
Secondary Outcome Measure Information:
Title
probing pocket depth
Description
measured as the distance from the mucosal margin to the base of the deepest pocket of the implant
Time Frame
6 months
Title
plaque index (PI)
Description
marked with a score from 0 to 3. Grade 0: no plaque; Grade 1: plaques could be found on the surface of the implant after scratching with the probe tip gently; Grade 2: plaque could be seen by the naked eye; and Grade 3: a large amount of plaques could be seen
Time Frame
6 months
Title
Bleeding on probing (BoP)
Description
modified sulcus bleeding index (mSBI) . This index scores the bleeding on a zero to three scale, where 0: no bleeding, 1: isolated bleeding spots, 2: blood forms a confluent red line and 3: heavy or profuse bleeding.
Time Frame
6 months
Title
Mucosal recession (MR)
Description
measured as the distance from the mucosal margin and the implant abutment interface
Time Frame
6 months
Title
The change in bone level (BL)
Description
the distance (mm) between the implant shoulder and the bottom of the defect
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age > 18 years,
having at least one implant demonstrating bone defect ≥3 mm, which presented a probing depth of ≥5 mm with BOP and/or suppuration, implants had to be in function for >12 months,
no implant mobility and no evidence of occlusal overload,
no evidence of occlusal overload
presence of at least 2 mm of keratinized attached mucosa .
Exclusion Criteria:
serious systemic diseases, medications or conditions that would contraindicate periodontal surgery and compromise wound healing,
history of taking systemic antibiotic during the past 3 months,
smoking,
pregnant or lactating females,
implants previously augmented with bone substitute or placed in grafted bone,
implants previously treated for peri-implantitis,
a mobile implant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Aggour, Dr
Organizational Affiliation
Oral Medicine & Periodontology department
Official's Role
Study Director
Facility Information:
Facility Name
October 6 University
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
12566
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin
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