Regenerative Surgical Treatment of Peri-implantitis Using Nanobone With or Without Simvastatin (RAS)

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Other: bone substitute; NanoBone®

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • El-Sheikh Zayed City, Giza, Egypt, 12566
      • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age > 18 years,
2. 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,
3. no implant mobility and no evidence of occlusal overload,
4. no evidence of occlusal overload
5. presence of at least 2 mm of keratinized attached mucosa .

Exclusion Criteria:

1. serious systemic diseases, medications or conditions that would contraindicate periodontal surgery and compromise wound healing,
2. history of taking systemic antibiotic during the past 3 months,
3. smoking,
4. pregnant or lactating females,
5. implants previously augmented with bone substitute or placed in grafted bone,
6. implants previously treated for peri-implantitis,
7. a mobile implant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bone substitute; NanoBone® (group 1, control group); a synthetic bone substitute consisting of nanocrystalline hydroxyapatite and silica fabricated in a sol-gel process.	Other: bone substitute; NanoBone®; surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.; Other Names: simvastatin
Experimental: simvastatin + NanoBone (group 2, test group); medications used to treat hypercholesterolemia	Other: bone substitute; NanoBone®; surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.; Other Names: simvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
probing pocket depth	measured as the distance from the mucosal margin to the base of the deepest pocket of the implant	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	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.	6 months
Mucosal recession (MR)	measured as the distance from the mucosal margin and the implant abutment interface	6 months
The change in bone level (BL)	the distance (mm) between the implant shoulder and the bottom of the defect	6 months

Collaborators and Investigators

• Sponsor: Reham Lotfy Aggour
• Collaborators: October 6 University
• Investigators: Study Director: Reham Aggour, Dr, Oral Medicine & Periodontology department

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): June 3, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: dental implant; surgical treatment; peri-implantitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: (IEC)/15-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No