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.
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
- Recruiting
Faculty of Dentistry - Cairo University
Cairo
Amr Zahran, PhD, amr.zahran@dentistry.cu.edu.eg
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.
- Conditions
- Implant Stability
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
Pain
Measured using Numerical Rating Scale
Measured: Measured 7 and 14 days post-implant placement
Swelling
Measured using verbal rating scale, categorized as either (VRS) Absent-slight-moderate- Or intense
Measured: 7 days post-implant placement
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.
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.
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.
- First posted22 Jan 2021
- Study start1 Jun 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant StabilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maie Ismaiel mohammed Fathy, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability Of Dental Implants Placed In Healed Bony Sites Of Hyperlipidemic Patients: A Case Series
- ClinicalTrials.gov ID
- NCT04718246
- Acronym / sponsor ID
- Maie2
- Conditions
- Implant Stability
- Keywords
- Hyperlipidemia, Implant survival, osseointegration, CBCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 22 Jan 2021 (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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Implants in hyperlipidemia patients | Other | Other: Dental Implants Placed In hyperlipidemia patientsImplants 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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 -
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 |
|---|---|---|
| Dental Implants Placed In hyperlipidemia patientsA 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 | Other | Dental Implants in hyperlipidemia patients |
Primary outcome
Implant stability
Time frame: At time of implant placement, 6 months post-implant placement
Outcome will be determined using sonance frequency analysis (RFA) (Osstell) periotest
5 secondary outcomes
Pain
Time frame: Measured 7 and 14 days post-implant placement
Swelling
Time frame: 7 days post-implant placement
Crestal bone level
Time frame: Same day as implant placement, 3 and 6 months post-implant.
Osseointegration
Time frame: Same day as implant placement, 3 and 6 months post-implant.
Implant survival
Time frame: 6 months post-implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
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.