Peri-ImplantitisRASNCT04559841
Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin
A study testing bone substitute; NanoBone® in people with Peri-Implantitis, run by Reham Lotfy Aggour at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- bone substitute; NanoBone®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Oct 2017to 15 Aug 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin: A 6-month Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- bone substitute; NanoBone®
- Keywords
- dental implant, peri-implantitis, surgical treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone substitute; NanoBone®Other
Also called simvastatin
surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.
| Study group | Role | What they receive |
|---|---|---|
| bone substitute; NanoBone® (group 1, control group) | Active comparator | a synthetic bone substitute consisting of nanocrystalline hydroxyapatite and silica fabricated in a sol-gel process. Receives: Other: bone substitute; NanoBone® |
| simvastatin + NanoBone (group 2, test group) | Experimental | medications used to treat hypercholesterolemia Receives: Other: bone substitute; NanoBone® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession
Measured: 6 months
Secondary outcomes (5)
probing pocket depth
measured as the distance from the mucosal margin to the base of the deepest pocket of the implant
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
Mucosal recession (MR)
measured as the distance from the mucosal margin and the implant abutment interface
Measured: 6 months
The change in bone level (BL)
the distance (mm) between the implant shoulder and the bottom of the defect
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start6 Oct 2017
- Primary completion3 Jun 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- single-center, parallel group, 6 month randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reham Lotfy Aggour
- Sponsor type
- University, hospital or other
- Collaborators
- October 6 University
- Responsible party
- Sponsor-investigator, Reham Lotfy Aggour, October 6 University
- Investigators
- Reham Aggour, Dr, Study director, Oral Medicine & Periodontology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559841
- Sponsor's protocol ID
- (IEC)/15-2017
- Acronym
- RAS
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin: A 6-month Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04559841
- Acronym / sponsor ID
- RAS / (IEC)/15-2017
- Conditions
- Peri-Implantitis
- Keywords
- dental implant, peri-implantitis, surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Reham Lotfy AggourUniversity, hospital or other
- Collaborators
- October 6 University
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 23 Sep 2020 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, parallel group, 6 month randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| bone substitute; NanoBone® (group 1, control group) | Active comparator | Other: bone substitute; NanoBone®a synthetic bone substitute consisting of nanocrystalline hydroxyapatite and silica fabricated in a sol-gel process. |
| simvastatin + NanoBone (group 2, test group) | Experimental | Other: bone substitute; NanoBone®medications used to treat hypercholesterolemia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| bone substitute; NanoBone®Also: simvastatinsurgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin. | Other | bone substitute; NanoBone® (group 1, control group), simvastatin + NanoBone (group 2, test group) |
Primary outcome
Clinical attachment level (CAL)
Time frame: 6 months
Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession
5 secondary outcomes
probing pocket depth
Time frame: 6 months
plaque index (PI)
Time frame: 6 months
Bleeding on probing (BoP)
Time frame: 6 months
Mucosal recession (MR)
Time frame: 6 months
The change in bone level (BL)
Time frame: 6 months
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 23 Sep 2020.
- 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. This study is not recruiting at the moment.
Reham Aggour, Dr study director
Oral Medicine & Periodontology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone substitute; NanoBone® in people with Peri-Implantitis, run by Reham Lotfy Aggour at 1 site in Egypt.
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 7 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 23 Sep 2020. 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 Egypt. 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?
Clinical attachment level (CAL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2020.