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

NCT04559841 | Completed DMC

• 1 other identifier: (IEC)/15-2017
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

dental implant; peri-implantitis; surgical treatment

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level (CAL)

  Clinical attachment level (CAL) defined as probing pocket depth + mucosal recession

  6 months

Secondary Outcomes (5)

• probing pocket depth

  6 months

• plaque index (PI)

  6 months

• Bleeding on probing (BoP)

  6 months

• Mucosal recession (MR)

  6 months

• The change in bone level (BL)

  6 months

Study Arms (2)

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.

Other: bone substitute; NanoBone®

simvastatin + NanoBone (group 2, test group)

EXPERIMENTAL

medications used to treat hypercholesterolemia

Other: bone substitute; NanoBone®

Interventions

bone substitute; NanoBone® OTHER

surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.

Also known as: simvastatin

bone substitute; NanoBone® (group 1, control group); simvastatin + NanoBone (group 2, test group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reham Lotfy Aggour: lead
• October 6 University: collaborator

Study Sites (1)

October 6 University

El-Sheikh Zayed City, Giza Governorate, 12566, Egypt

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Bone Substitutes; NanoBone; Simvastatin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Reham Aggour, Dr

  Oral Medicine & Periodontology department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single examiner blinded to the treatment assignment was responsible for evaluating the clinical parameters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor of Oral Medicine, diagnosis & Periodontology

Model Details: single-center, parallel group, 6 month randomized clinical trial

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 23, 2020
• Study Start: October 6, 2017
• Primary Completion: June 3, 2020
• Study Completion: August 15, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

EG (1)