Stability Of Dental Implants Placed In Healed Bony Sites Of Hyperlipidemic Patients: A Case Series

NCT04718246 | Unknown

• 1 other identifier: Maie2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of the problem: Osseo-integration of dental implants depends mainly on bone regeneration around dental implant. Hyperlipidemia has significant adverse effects on bone health, leading to lower bone mineral density and to higher risk of osteoporosis and bone fracture (Corwin 2003; Pirih, Lu et al. 2012). The effects of hyperlipidemia on bone health may also interfere with dental implant therapy since the host's bone quantity, quality and healing potential play an important role in osseointegration (Fedele, Sabbah et al. 2011; Gaetti-Jardim, Santiago-Junior et al. 2011; Olivares-Navarrete, Raines et al. 2012). Rationale for conducting the research: Hyperlipidemia has been associated with the pathophysiology of major diseases, such as atherosclerosis and osteoporosis. A high cholesterol level has significant adverse effects on bone, including lower bone density, volume and strength. Statins, drugs that lower serum cholesterol levels have beneficial effects on bone metabolism. Since host's bone quantity, quality and healing potential play a crucial role in osseointegration of dental implants, it was hypothesized that hyperlipidemia may negatively affect implant osseointegration.

Conditions

Implant Stability

Keywords

Hyperlipidemia; Implant survival; osseointegration; CBCT

Outcome Measures

Primary Outcomes (1)

• Implant stability

  Outcome will be determined using sonance frequency analysis (RFA) (Osstell) periotest

  At time of implant placement, 6 months post-implant placement

Secondary Outcomes (5)

• Pain

  Measured 7 and 14 days post-implant placement

• Swelling

  7 days post-implant placement

• Crestal bone level

  Same day as implant placement, 3 and 6 months post-implant.

• Osseointegration

  Same day as implant placement, 3 and 6 months post-implant.

• Implant survival

  6 months post-implant placement

Study Arms (1)

Dental Implants in hyperlipidemia patients

OTHER

Implants will be placed at T0, then Implant site exposure will take place 6 months following the implant placement. Insertion of the healing collars in order to obtain adequate soft tissue form for 1-2 weeks then the impressions (indirect, closed tray echnique) shall be taken to fabricate the final crowns, then the final crowns will be fitted in place.

Other: Dental Implants Placed In hyperlipidemia patients

Interventions

Dental Implants Placed In hyperlipidemia patients OTHER

A preoperative cone beam CT (CBCT) will be performed for each patient prior to the surgery. Surgical phase (T0): After local anesthetics, all osteotomies will be prepared by the same operator, using a drilling speed of 1200 rpm, under copious irrigation with normal saline. * Penetration of cortical bone will be achieved with no. 6 round burs. * The osteotomies will be widened, using a drill 1 mm larger than the final drill provided by the manufacturer. The final size of the control osteotomies were same diameter of the implant. * Periotest® will measure initial implant stability. Implant site exposure will take place 6 months following the implant placement. Insertion of the healing collars in order to obtain adequate soft tissue form for 1-2 weeks

Dental Implants in hyperlipidemia patients

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who have at least one missing tooth.
• Patient with hyperlipidemia (LDL \< 160 mg/dl )
• Patients with sufficient interarch space.
• Patients aged from 20 to 60 years old.
• Good oral hygiene.(Wiesner et al. 2010)
• Accepts 6 months follow-up period (cooperative patients)
• Patient provides an informed consent.

You may not qualify if:

• Patients with signs of acute infection related to the area of interest.
• Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
• Current and former smokers (Lambert et al, 2000)
• Pregnant women.
• Psychological problems -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Amr Zahran, PhD

CONTACT

+20 120 000 6635; amr.zahran@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 17, 2021
• First Posted: January 22, 2021
• Study Start: June 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)