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Implant StabilityNCT04718246

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

A study testing Dental Implants Placed In hyperlipidemia patients in people with Implant Stability, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Implant Stability
What is being tested?
Dental Implants Placed In hyperlipidemia patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
1 Jun 2020to 1 Aug 2021
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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 -

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Faculty of Dentistry - Cairo University

    Cairo

    Amr Zahran, PhD, amr.zahran@dentistry.cu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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).

Read more

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.

Read the detailed description

The high predictability of dental implants has led to routine use with a great expectation for success. There are many researches focused on the outcome of delayed dental implant. Since the first report of highly success rate after placement of a dental implant, there has been increasing interest in this technique for implant treatment (Chen ST., 2004) The goal of modern dentistry is to restore the patient's dentition to normal contour, function, comfort, esthetics, speech and health regardless of the atrophy, disease or injury of the stomatognathic system, as a result of disease related tooth loss and the value placed upon teeth, there has been a continual search for methods by which missing teeth could be replaced. Early artificial replacements were made from natural teeth and a variety of substitute materials. All transplantation of a tooth from one person to another was an early method by which lost teeth were replaced. Archeological discoveries indicate that many ancient civilizations practiced allogenic tooth transplantation. In 1561, Ambrose Pare reported that decayed teeth could be replaced by using extracted teeth from another individual and is credited with being the first to mention transplantation (Chiu YW., 2015) Periimplant osteogenesis consists of postsurgical reaction and remodeling of the bone and the initiation and progression of de novo bone formation, which are represented as a reduction in primary stability and development of secondary stability, respectively (Ogawa and Nishimura, 2003, Aparicio et al., 2006, Atsumi et al., 2007). Dental implant survival is mainly dependent on successful osseointegration following placement. Any alteration of this biological process may adversely affect the success rate. Also, the long-term prognosis is adversely affected by inadequate bone volume at implant sites. There are several risk factors that were defined as implant failure. One of the risks of implant's failure depends on the systemic health of the subject (such as diabetes mellitus, osteoporosis, smoking) Recently, some authors suggested that there is a relationship between hypercholesterolemia and dental implant osseointegration (Keuroghlian A et al.. 2015, Tirone F et al. 2016). Hyperlipidemia is a state with an abnormal lipid pro- file, which is characterized by elevated blood concentrations of triglycerides, elevated levels of total cholesterol and LDL, and decreased levels of HDL cholesterol ( Saxlin T., 2008) Hyperlipidemia is associated with several diseases such as atherosclerosis and osteoporosis. The National Health and Nutrition Examination Survey (NHANES III) reported that 63% of osteoporotic patients have hyperlipidemia (Bilezikian JP., 2005) The main mechanisms of the relationship between hyperlipidemia and bone tissue metabolism are the involved aspects of some metabolic changes, including lower bone mineral density, increase in the number of osteoclasts, and the inhibition of osteoblastic activity. However, several investigators suggested that lipid- lowering drugs, such as statins, had beneficial effects on bone metabolism and also favorable effects on statins observed on osteogenesis around implants (Moriyama Y et al., 2010). Recently many papers focused on High cholesterol and its impact effect on bone turn over around dental implant but all of them are animal studies. Mish (2008) defined four bone density groups (D1 to D4) found in all jaw regions varying according to macroscopic cortical and trabecular bone types. D1 is dense and homogenous type of bone that is often found in anterior mandibles. D2 is a combination of dense-to-porous cortical bone on the crest and coarse trabecular bone on the inside. D3 is composed of thinner porous cortical bone on the crest and fine trabecule. Mish (2008) defined four bone density groups (D1 to D4) found in all jaw regions varying according to macroscopic cortical and trabecular bone types. D1 is dense and homogenous type of bone that is often found in anterior mandibles. D2 is a combination of dense-to-porous cortical bone on the crest and coarse trabecular bone on the inside. D3 is composed of thinner porous cortical bone on the crest and fine trabecular bone within the ridge. The D2 bone trabeculae are 40% to 60% stronger than D3 trabeculae. D4 bone has very little density and little or no cortical crestal bone. It is the opposite of D1. The most common locations for D4 type of bone are the posterior region of the maxilla. D4 bone trabeculae may be up to 10 times weaker than the cortical bone of D1 and the bone-implant contact after initial loading is often less than 25%. Bone trabeculae are sparse and, as a result, initial fixation of any implant design presents a surgical challenge (Dvorak G., 2011) Primary or secondary implant stability usually measured by Periotest or Ostell, Periotest measuring procedure is electromechanical. An electrically driven and electronically monitored tapping head percusses the implant 16 times. The entire measuring procedure requires approx. 4 seconds. The tapping head is pressure sensitive and records the duration of contact with the test object. Loose implants display a longer contact time and the Periotest values are correspondingly higher, while osseointegrated implants have a short contact time and result in low Periotest values. Periotest values (PTV) of (-8 to +50) were -ve values considered the ideal values that denote successful osseointegration (Molly L., 2006). Although the ever-increasing number of published animal studies on this topic, there is however no consensus regarding dental implants stability in patients with hyperlipidemia.

Being tested
Dental Implants Placed In hyperlipidemia patients
Keywords
Hyperlipidemia, Implant survival, osseointegration, CBCT
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental Implants Placed In hyperlipidemia patientsOther

    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
Study groups in NCT04718246
Study groupRoleWhat they receive
Dental Implants in hyperlipidemia patientsOtherImplants 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.
Receives: Other: Dental Implants Placed In hyperlipidemia patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implant stability

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

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

Secondary outcomes (5)
  1. Pain

    Measured using Numerical Rating Scale

    Measured: Measured 7 and 14 days post-implant placement

  2. Swelling

    Measured using verbal rating scale, categorized as either (VRS) Absent-slight-moderate- Or intense

    Measured: 7 days post-implant placement

  3. Crestal bone level

    Digital periapical radiograph using a radiographic holder and an acrylic radiographic stent -which is constructed previously on patient's cast= will be taken to determine the crestal bone level and resorption. The parallel technique in combination with the acrylic stent is performed to ensure reproducibility.

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

  4. Osseointegration

    Digital periapical radiograph using a radiographic holder and an acrylic radiographic stent -which is constructed previously on patient's cast= will be taken to determine the crestal bone level and resorption. The parallel technique in combination with the acrylic stent is performed to ensure reproducibility.

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

  5. Implant survival

    Assessed as a dicotomous outcome (Yes/No)

    Measured: 6 months post-implant placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Jun 2020
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718246
Sponsor's protocol ID
Maie2
Status last verified
Jan 2021
First submitted
17 Jan 2021
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dental Implants Placed In hyperlipidemia patients in people with Implant Stability, run by Cairo University 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amr Zahran, PhD (+20 120 000 6635, amr.zahran@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant stability (time frame: At time of implant placement, 6 months post-implant placement). 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 22 Jan 2021.

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