ImplantNCT07187609
Zinc Incorporated Bovine Derived- Hydroxyappatite Xenograft in Immediately Placed Implant
A study testing Immediate implant with bovine drived hydroxyapatite xenograft. and immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft in people with Implant and Zinc Status, run by Suez Canal University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate Clinical and radiographic effect of zinc incorporated bovine derived hydroxyapatite xenograft and bovine hydroxyapatite xenograft alone for immediately placed implant Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant, Zinc Status
- What is being tested?
- Immediate implant with bovine drived hydroxyapatite xenograft. and immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Aug 2025to 8 Oct 2026
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult(male or female) patients between the ages of 30 - 55 years who requiring the replacement of one or more non-restorable teeth in the mandible which will be indicated for extraction.
- Adequate bone dimensions at the implant site with ridge width of at least 6 mm, the availability of at least 3mm of sound subapical bone, the presence of an intact labial bone plate, and no evidance of periapical infection on cone beam computed tomography or clinically
- The peri-implant gaps larger than 1.5 mm will be included.
- All patients will be physically healthy with no medical history of any systemic disease.
Who cannot join
- Smokers.
- Patients with para functional habits such as bruxism and clenching
- Poorly controlled systemic diseases which preclude local anesthesia or surgical procedures
- Patients undergoing chemotherapy or radiotherapy and immuno-compromised patients.
- Pregnant /lactating women.
- Patients that are allergic to zinc
- Patients on antibiotic therapy in the pervious 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zinc Incorporated Bovine Derived- Hydroxyappatite Xenograft in the Jumping Gap of Immediately Placed Implant: A Randomized Clinical Study
The aim of this study is to evaluate Clinical and radiographic effect of zinc incorporated bovine derived hydroxyapatite xenograft and bovine hydroxyapatite xenograft alone for immediately placed implant
Read the detailed description
Implant dentistry is a prosthetic effort via a surgical procedure. In order to achieve an ideal prosthetic construct, precise plan should be taken into consideration prior to the beginning of treatment. The position of implant requires protected prosthesis. It can be affected by the implant size, volume, and the quantity and quality of bone provided at various sites.
One pitfall of immediate implant use, however, is the inevitable residual space that remains between the implant body and the socket wall, due to a discrepancy in size between the implant and the socket wall. This space, which is located toward the coronal end of the implant, is called the jumping distance. Excessive jumping distance may lead to bone resorption and formation of a bony defect, decreasing the implant stability .
One of the most extensively used methods for restoration of the lost attachment is the use of bone grafts. bone grafting which is one of the methods used to address these issues has experienced an increased level of demand.
The problem of bone defects has also contributed to making bone autograft become the gold standard for treating bone abnormalities, although it has its limitations which are graft quantity and donor site morbidity. Contributory,allografts have become popular for replacing bone defects because the graft size can be easily adjusted but it also has several drawbacks, including disease transfer, rejection reactions, non-union, graft resorption, fracture, and donor restrictions A xenograft is one of the choices used to overcome these limitations since the raw material is plentiful, readily available, and inexpensive. Additionally, several previous studies showed that organic or inorganic matrix derived from bovine bone is biocompatible, but this biomaterial requires proper preparation to avoid risks such as the transmission of zoonoses .
Bovine hydroxyapatite is made up of materials which have biological properties that makes it biocompatible and osteoconductive. These important biological properties allow the apposition of newly formed bone by osteoprogenitor cells and the partial remodeling by osteoclast and osteoblast of the host . Hydroxyapatite is used as scaffolds to support the development of bone tissue from an osteoblast proliferation stage through to extracellular matrix (ECM) deposition and on to cell-mediated early-stage mineralization. The addition of small quantities of hydroxyapatite to the scaffolds considerably increases calcium deposition and has a mild osteogenic impact.
One of the potential methods for producing anorganic xenograft with enhanced osteoconductivity is by substituting ions with the constituent elements of hydroxyapatite that exist in bone mineral because this method has the potential to increase hydroxyapatite solubility by lowering its crystallinity and inducing a higher number of structural defects. For these reasons, the ionic activity product of apatite increases in body fluid due to the released constituent elements of apatite and this will provoke the formation of low crystalline hydroxyl carbonate apatite (bioactivity) on ions substituted hydroxyapatite surface, which enhances osteoconductivity. However, the effect of other ions in bone on the bioactivity and osteoconductivity of hydroxyapatite has not been extensively investigated. The substitutions of sodium with calcium ions and chlorine with hydroxyl ions in hydroxyapatite have been also reported, respectively, but they were confined to synthetic procedures and structural analyses.
Zinc is the most abundant trace metallic element found in the body with 85% present in muscle and bone. Zinc has proven to possess a direct stimulatory effect on osteoblastic cells in vitro while bone resorption was inhibited . It also reduces bacterial load, thus proving its antimicrobial properties. Many studies have demonstrated that zinc significantly improved the bioactivity of HA. Therefore, zinc-HA can be a new generation of materials for bone tissue- engineering.
In comparison with the pure HA group, Zn2+-doped HA had more connective tissues replaced by rebuilt bones, confirming that Zn2+-doped HA had a stronger osteo-induction potential.
In a word, Zn2+ ions act in promoting cell proliferation, increasing osteogenic activity, and inhibiting osteoclast bioactivity. Zn2+-doped HA was considered as a suitable substitute for cancellous bone.
To the best of our knowledge there are no studies conducted on zinc incorporation bovine derived hydroxyapatite xenograft (Zn-BHA) on immediate implant so this study designed to evaluate the effect of bovine drived hydroxyapatite xenograft (BHA) alone and zinc incorporated bovine drived hydroxyapatite xenograft clinically and radographically on immediat implant.
With the advancement of computer-aided design and computer-aided manufacturing (CAD-CAM) technology, there are different approaches for implant prosthetics' digital workflow.
Recent digital technology allowed the virtual extraction of unrestorable teeth, the design of a restoration with a perfect emergence profile that preserves soft tissue contour, and finally the 3D printing of the interim restoration.
The CAD-CAM guided templates have many applications in dentistry such as implant placement and endodontic access preparations, the guided implant osteotomy presents an accurate protocol for implant placement in the preplanned position with less surgical time and few post-surgical complications.
The digitally designed surgical guides transfer the virtually planned implant angulation, width and length through the use of 3D printed transparent template.
- Conditions
- Implant, Zinc Status
- Being tested
- Immediate implant with bovine drived hydroxyapatite xenograft., immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft
- Keywords
- bone grafts, Implant, zinc in corporated bovine drived hydroxyappatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant with bovine drived hydroxyapatite xenograft.Procedure or surgery
patients will undergo immediate implant with bovine drived hydroxyapatite xenograft.
immediate implant with zinc incorporated bovine drived hydroxyapatite xenograftProcedure or surgery
patients will undergo immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft
| Study group | Role | What they receive |
|---|---|---|
| Group I (control) | Experimental | patients will undergo immediate implant with bovine drived hydroxyapatite xenograft Receives: Procedure: Immediate implant with bovine drived hydroxyapatite xenograft. |
| Group II (Test group) | Experimental | patients will undergo immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft Receives: Procedure: immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Marginal bone loss was defined as the distance from the implant platform to the alveolar crest.
Measured: 9 months
Secondary outcomes (1)
densitometric gray scale value to measure bone density
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start13 Aug 2025
- Primary completion8 Oct 2026
- Study completion8 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim montasser, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187609
- Sponsor's protocol ID
- Zinc in immediate implant
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2025
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Incorporated Bovine Derived- Hydroxyappatite Xenograft in the Jumping Gap of Immediately Placed Implant: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07187609
- Acronym / sponsor ID
- Zinc in immediate implant
- Conditions
- Implant, Zinc Status
- Keywords
- bone grafts, Implant, zinc in corporated bovine drived hydroxyappatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 8 Oct 2026 (actual)
- Study completion
- 8 Oct 2026 (actual)
- First posted
- 23 Sep 2025 (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.
The aim of this study is to evaluate Clinical and radiographic effect of zinc incorporated bovine derived hydroxyapatite xenograft and bovine hydroxyapatite xenograft alone for immediately placed implant
Detailed description
Implant dentistry is a prosthetic effort via a surgical procedure. In order to achieve an ideal prosthetic construct, precise plan should be taken into consideration prior to the beginning of treatment. The position of implant requires protected prosthesis. It can be affected by the implant size, volume, and the quantity and quality of bone provided at various sites.
One pitfall of immediate implant use, however, is the inevitable residual space that remains between the implant body and the socket wall, due to a discrepancy in size between the implant and the socket wall. This space, which is located toward the coronal end of the implant, is called the jumping distance. Excessive jumping distance may lead to bone resorption and formation of a bony defect, decreasing the implant stability .
One of the most extensively used methods for restoration of the lost attachment is the use of bone grafts. bone grafting which is one of the methods used to address these issues has experienced an increased level of demand.
The problem of bone defects has also contributed to making bone autograft become the gold standard for treating bone abnormalities, although it has its limitations which are graft quantity and donor site morbidity. Contributory,allografts have become popular for replacing bone defects because the graft size can be easily adjusted but it also has several drawbacks, including disease transfer, rejection reactions, non-union, graft resorption, fracture, and donor restrictions A xenograft is one of the choices used to overcome these limitations since the raw material is plentiful, readily available, and inexpensive. Additionally, several previous studies showed that organic or inorganic matrix derived from bovine bone is biocompatible, but this biomaterial requires proper preparation to avoid risks such as the transmission of zoonoses .
Bovine hydroxyapatite is made up of materials which have biological properties that makes it biocompatible and osteoconductive. These important biological properties allow the apposition of newly formed bone by osteoprogenitor cells and the partial remodeling by osteoclast and osteoblast of the host . Hydroxyapatite is used as scaffolds to support the development of bone tissue from an osteoblast proliferation stage through to extracellular matrix (ECM) deposition and on to cell-mediated early-stage mineralization. The addition of small quantities of hydroxyapatite to the scaffolds considerably increases calcium deposition and has a mild osteogenic impact.
One of the potential methods for producing anorganic xenograft with enhanced osteoconductivity is by substituting ions with the constituent elements of hydroxyapatite that exist in bone mineral because this method has the potential to increase hydroxyapatite solubility by lowering its crystallinity and inducing a higher number of structural defects. For these reasons, the ionic activity product of apatite increases in body fluid due to the released constituent elements of apatite and this will provoke the formation of low crystalline hydroxyl carbonate apatite (bioactivity) on ions substituted hydroxyapatite surface, which enhances osteoconductivity. However, the effect of other ions in bone on the bioactivity and osteoconductivity of hydroxyapatite has not been extensively investigated. The substitutions of sodium with calcium ions and chlorine with hydroxyl ions in hydroxyapatite have been also reported, respectively, but they were confined to synthetic procedures and structural analyses.
Zinc is the most abundant trace metallic element found in the body with 85% present in muscle and bone. Zinc has proven to possess a direct stimulatory effect on osteoblastic cells in vitro while bone resorption was inhibited . It also reduces bacterial load, thus proving its antimicrobial properties. Many studies have demonstrated that zinc significantly improved the bioactivity of HA. Therefore, zinc-HA can be a new generation of materials for bone tissue- engineering.
In comparison with the pure HA group, Zn2+-doped HA had more connective tissues replaced by rebuilt bones, confirming that Zn2+-doped HA had a stronger osteo-induction potential.
In a word, Zn2+ ions act in promoting cell proliferation, increasing osteogenic activity, and inhibiting osteoclast bioactivity. Zn2+-doped HA was considered as a suitable substitute for cancellous bone.
To the best of our knowledge there are no studies conducted on zinc incorporation bovine derived hydroxyapatite xenograft (Zn-BHA) on immediate implant so this study designed to evaluate the effect of bovine drived hydroxyapatite xenograft (BHA) alone and zinc incorporated bovine drived hydroxyapatite xenograft clinically and radographically on immediat implant.
With the advancement of computer-aided design and computer-aided manufacturing (CAD-CAM) technology, there are different approaches for implant prosthetics' digital workflow.
Recent digital technology allowed the virtual extraction of unrestorable teeth, the design of a restoration with a perfect emergence profile that preserves soft tissue contour, and finally the 3D printing of the interim restoration.
The CAD-CAM guided templates have many applications in dentistry such as implant placement and endodontic access preparations, the guided implant osteotomy presents an accurate protocol for implant placement in the preplanned position with less surgical time and few post-surgical complications.
The digitally designed surgical guides transfer the virtually planned implant angulation, width and length through the use of 3D printed transparent template.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (control) | Experimental | Procedure: Immediate implant with bovine drived hydroxyapatite xenograft.patients will undergo immediate implant with bovine drived hydroxyapatite xenograft |
| Group II (Test group) | Experimental | Procedure: immediate implant with zinc incorporated bovine drived hydroxyapatite xenograftpatients will undergo immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult(male or female) patients between the ages of 30 - 55 years who requiring the replacement of one or more non-restorable teeth in the mandible which will be indicated for extraction.
- Adequate bone dimensions at the implant site with ridge width of at least 6 mm, the availability of at least 3mm of sound subapical bone, the presence of an intact labial bone plate, and no evidance of periapical infection on cone beam computed tomography or clinically
- The peri-implant gaps larger than 1.5 mm will be included.
- All patients will be physically healthy with no medical history of any systemic disease.
Key exclusion criteria (7 listed)
- Smokers.
- Patients with para functional habits such as bruxism and clenching
- Poorly controlled systemic diseases which preclude local anesthesia or surgical procedures
- Patients undergoing chemotherapy or radiotherapy and immuno-compromised patients.
- Pregnant /lactating women.
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 |
|---|---|---|
| Immediate implant with bovine drived hydroxyapatite xenograft.patients will undergo immediate implant with bovine drived hydroxyapatite xenograft. | Procedure or surgery | Group I (control) |
| immediate implant with zinc incorporated bovine drived hydroxyapatite xenograftpatients will undergo immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft | Procedure or surgery | Group II (Test group) |
Primary outcome
Marginal bone loss
Time frame: 9 months
Marginal bone loss was defined as the distance from the implant platform to the alveolar crest.
1 secondary outcome
densitometric gray scale value to measure bone density
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant with bovine drived hydroxyapatite xenograft. and immediate implant with zinc incorporated bovine drived hydroxyapatite xenograft in people with Implant and Zinc Status, run by Suez Canal 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 6 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss (time frame: 9 months). 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 6 Nov 2026.