Immediate Implant PlacementNCT06842368
Immediate Implant Placement Using Xenograft Mixed with Vitamin D Versus Hyaluronic Acid.
A study testing Hyaluronic Acid (HA) and Vitamin D in people with Immediate Implant Placement, run by Cairo University at 1 site in Egypt.
Trial summary
Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement
- What is being tested?
- Hyaluronic Acid (HA) and Vitamin D
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60.
- Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth region.
- Absence of any peri-apical pathosis.
- Patients with intact buccal plate of bone.
- Patients with adequate bone volume for the dental implant procedure.
- Patient with good oral hygrine
Who cannot join
- Heavy Smokers.
- Systemic disease that may affect the final outcome of the surgical procedure.
- No or poor patient's compliance.
- Patients with psychological problems.
- Pathology at the site of intervention.
- Patient with vit d deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry ,Cairo university
Cairo
About this study
Official title: Immediate Implant Placement Using Xenograft As Space Filling Material Mixed with Vitamin D Versus Hyaluronic Acid in Posterior Mandible Region: a Randomized Controlled Clinical Trial.
Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region
Read the detailed description
Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk.
The application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.
- Conditions
- Immediate Implant Placement
- Being tested
- Hyaluronic Acid (HA), Vitamin D
- Keywords
- Hyaluronic acid, Vitamin D, Xenograft, Immediate Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Procedure or surgery
Hyaluronic acid is one of the essential components of extracellular matrix, which plays a predominant role in tissue morphogenesis, cell migration, differentiation, and adhesion. It has been recently reported that hyaluronic acid increases osteoblastic bone formation in vitro through increased mesenchymal cell differentiation and migration.
It has demonstrated that Hyaluronic acid not only acted as a carrier of growth factors and cell but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts.
Although Hyaluronic acid shares bone induction properties with growth factors as bone morphogenic protein 2 and osteopontin
Vitamin DProcedure or surgery
It was shown that locally applied vitamin D3 in combination with bovine bone mineral matrix improved the bone formation and strengthened the site of the fracture in ovariectomized rats.
Local application of vitamin D3 also proved to be promising in promoting osteo- genesis and mineralization for restoration of bone defects. Grounding on this incites, it has been suggested that vitamin D3 might exert a positive local effect on alveolar bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D mixed with Xenograft as space filling material after placement of immediate implant. | Experimental | Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with Vitamin D and the socket will sealed using 4-0 resorbable sutures. Receives: Procedure: Vitamin D |
| Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant. | Active comparator | Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid and the socket will sealed using 4-0 resorbable sutures. Receives: Procedure: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant secondary stability
To evaluate the implant stability by Any-check device.
Measured: after 6 months
Secondary outcomes (1)
Density of bone around implant
Cone beam computed tomography CBCT
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start2 Feb 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immediate Implant PlacementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Clinical Trial. Parallel group study. Allocation Ratio 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Mohamad Adib Eiz Eddin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842368
- Sponsor's protocol ID
- A.M.A.E
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abd Elwahap, Mohammad et al. "Effect of Xenograft Alone versus Xenograft Mixed with Vitamin-D On Preservation of Alveolar Sockets of Chronically Infected Teeth." Al-Azhar Journal of Dental Science (2024): n. pag.
⦁ Elgazzar, A., Yousef, E., Amer, M. Effect of Hyaluronic Acid Mixed with Biphasic Calcium Phosphate on Bone Healing Around Immediately Placed Implants in the Posterior Area of the Mandible. Egyptian Dental Journal, 2023; 69(4): 2631-2641. doi: 10.21608/edj.2023.227200.2669
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement Using Xenograft As Space Filling Material Mixed with Vitamin D Versus Hyaluronic Acid in Posterior Mandible Region: a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06842368
- Acronym / sponsor ID
- A.M.A.E
- Conditions
- Immediate Implant Placement
- Keywords
- Hyaluronic acid, Vitamin D, Xenograft, Immediate Implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Feb 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.
Immediate implant placement using xenograft as space filling material mixed with vitamin D versus hyaluronic acid in posterior mandible region This study aims to evaluate implant stability and density after placement of immediate implant and Xenograft mixed with Hyaluronic acid or Vitamin D at posterior mandible region
Detailed description
Dental implants in fresh extraction sockets and healed sites have a erratic morphology, creating a wide space defect between the implant and buccal alveolar bone. This defect is critical for implant success, known as a jumping gap. Proper management of this space is essential for esthetic and functional success. Studies show adequate bone fill can be achieved in jumping gaps, but wider gaps increase implant body exposure risk.
The application of biological mediators embedded in the biomaterial can induce specific cell and tissue response, which can improve bone quality and quantity. Dental research has focused on improving bone substitutes by morphologic or bio- chemical modification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Clinical Trial. Parallel group study. Allocation Ratio 1:1.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D mixed with Xenograft as space filling material after placement of immediate implant. | Experimental | Procedure: Vitamin DCareful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with Vitamin D and the socket will sealed using 4-0 resorbable sutures. |
| Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant. | Active comparator | Procedure: Hyaluronic Acid (HA)Careful extraction of the selected tooth will initiated using sharp periotome to sever the periodontal ligament attachments while preserving the surrounding alveolar bone and interdental papilla and followed by using extraction forceps. Meticulous mechanical debridement of the extraction socket will be carried out using bone curette to remove any soft tissue remnants or granulation tissue. All debris will washed out using copious saline irrigation. Implant osteotomy will then initiated engaging the furcation of the alveolus along with the remaining apical bone and while maintain jumping gap more than 2 mm between the implant platform and the alveolar. the jumping space will packed using Xenograft with particle size ranging from 0.25 to 1 mm and it will be mixed with hyaluronic acid and the socket will sealed using 4-0 resorbable sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-60.
- Systemically healthy patients indicated for single or multiple immediate implants in posterior teeth region.
- Absence of any peri-apical pathosis.
- Patients with intact buccal plate of bone.
- Patients with adequate bone volume for the dental implant procedure.
Key exclusion criteria (6 listed)
- Heavy Smokers.
- Systemic disease that may affect the final outcome of the surgical procedure.
- No or poor patient's compliance.
- Patients with psychological problems.
- Pathology at the site of intervention.
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 |
|---|---|---|
| Hyaluronic Acid (HA)Hyaluronic acid is one of the essential components of extracellular matrix, which plays a predominant role in tissue morphogenesis, cell migration, differentiation, and adhesion. It has been recently reported that hyaluronic acid increases osteoblastic bone formation in vitro through increased mesenchymal cell differentiation and migration. It has demonstrated that Hyaluronic acid not only acted as a carrier of growth factors and cell but also stimulated bone formation through chemotaxis, proliferation and differentiation of mesenchymal cells into osteoblasts. Although Hyaluronic acid shares bone induction properties with growth factors as bone morphogenic protein 2 and osteopontin | Procedure or surgery | Hyaluronic acid mixed with Xenograft as space filling material after placement of immediate implant. |
| Vitamin DIt was shown that locally applied vitamin D3 in combination with bovine bone mineral matrix improved the bone formation and strengthened the site of the fracture in ovariectomized rats. Local application of vitamin D3 also proved to be promising in promoting osteo- genesis and mineralization for restoration of bone defects. Grounding on this incites, it has been suggested that vitamin D3 might exert a positive local effect on alveolar bone regeneration | Procedure or surgery | Vitamin D mixed with Xenograft as space filling material after placement of immediate implant. |
Primary outcome
Implant secondary stability
Time frame: after 6 months
To evaluate the implant stability by Any-check device.
1 secondary outcome
Density of bone around implant
Time frame: after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- BackgroundAbd Elwahap, Mohammad et al. "Effect of Xenograft Alone versus Xenograft Mixed with Vitamin-D On Preservation of Alveolar Sockets of Chronically Infected Teeth." Al-Azhar Journal of Dental Science (2024): n. pag.
- Background⦁ Elgazzar, A., Yousef, E., Amer, M. Effect of Hyaluronic Acid Mixed with Biphasic Calcium Phosphate on Bone Healing Around Immediately Placed Implants in the Posterior Area of the Mandible. Egyptian Dental Journal, 2023; 69(4): 2631-2641. doi: 10.21608/edj.2023.227200.2669
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA) and Vitamin D in people with Immediate Implant Placement, 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AMMAR EIZ EDDIN (00201153383058, ammar.adib@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 secondary stability (time frame: after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06842368, which also lists 2 linked publications.
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 24 Feb 2025.