Dental ImplantsPhase 2/3NCT07199725
Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant.
A Phase 2/3 study testing immediate dental implant and immediate dental implant, natural bovine bone substitute material in people with Dental Implants, run by Suez Canal University at 1 site in Egypt.
Trial summary
the goal of this study is to evaluate the effective of natural bovine bone with hyaluronic acid on osseointegration of immediate implants in single rooted badly decayed maxillary anterior teeth and premolars. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- immediate dental implant and immediate dental implant, natural bovine bone substitute material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2022to 20 May 2023
- Phase
- Phase 2/3
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- medically free patients, good oral hygiene, no periapical lesions around teeth to be extracted
Who cannot join
- patients with bone or soft tissue defects, poor oral hygiene, heavy smoking, bruxism, severe periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant: A Randomized Clinical Study
the goal of this study is to evaluate the effective of natural bovine bone with hyaluronic acid on osseointegration of immediate implants in single rooted badly decayed maxillary anterior teeth and premolars. the main question it aims to answer is does natural bovine with hyaluronic acid affects osseointegration of immediate implants.
the study compares immediate implants followed by grafting with natural bovine bone with hyaluronic acid to immediate implants without grafting.
- Conditions
- Dental Implants
- Being tested
- immediate dental implant, immediate dental implant, natural bovine bone substitute material
- Keywords
- immediate dental implants, natural bovine bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate dental implantCombination product
control group: 8 teeth were extracted then 8 immediate implants were placed without bone grafting
immediate dental implant, natural bovine bone substitute materialCombination product
study group: 8 teeth were extracted then received 8 immediate implants followed by grafting with natural bovine bone substitute material with hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | control group: 8 immediate implants were inserted in 8 fresh extraction sockets without bone grafting. Receives: Combination Product: immediate dental implant |
| study group | Active comparator | study group: 8 immediate implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid Receives: Combination Product: immediate dental implant, natural bovine bone substitute material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
using cone beam CT bone density was measured around the implant in housefield units immediately after implant placement and after 6 months.
Measured: baseline (immediately) and 6 months
implant stability
using Osstell device, implant stability was measured immediately after implant placement and after 4 months
Measured: Baseline (immediately) and after 4 months
Secondary outcomes (1)
Bone width
using cone beam CT, buccal bone width was measured from the mid surface of the implant immediately after implant placement and after 6 months.
Measured: Baseline (immediately) and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start8 Nov 2022
- Primary completion15 Mar 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study was conducted on 16 badly decayed single rooted maxillary anterior teeth and premolars that received 16 immediate implants equally randomized divided into 2 groups. control group: 8 implants were inserted in 8 fresh extraction sockets study group: 8 implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid (act as study group).
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed wageh foad, Suez Canal University
- Investigators
- Mohamed Said professor, Study director, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199725
- Sponsor's protocol ID
- 544/2022
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Foad MW, El Rawdy AM, Hamed MS. Clinical and radiographic evaluation of natural bovine bone with hyaluronic acid on osseointegration of immediate implants: a randomized clinical study. Sci Rep. 2026 Aug 6;16(1):24308. doi: 10.1038/s41598-026-64165-9.
PubMed 42562852
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07199725
- Acronym / sponsor ID
- 544/2022
- Conditions
- Dental Implants
- Keywords
- immediate dental implants, natural bovine bone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 30 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 goal of this study is to evaluate the effective of natural bovine bone with hyaluronic acid on osseointegration of immediate implants in single rooted badly decayed maxillary anterior teeth and premolars. the main question it aims to answer is does natural bovine with hyaluronic acid affects osseointegration of immediate implants.
the study compares immediate implants followed by grafting with natural bovine bone with hyaluronic acid to immediate implants without grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This clinical study was conducted on 16 badly decayed single rooted maxillary anterior teeth and premolars that received 16 immediate implants equally randomized divided into 2 groups. control group: 8 implants were inserted in 8 fresh extraction sockets study group: 8 implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid (act as study group).
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Combination Product: immediate dental implantcontrol group: 8 immediate implants were inserted in 8 fresh extraction sockets without bone grafting. |
| study group | Active comparator | Combination Product: immediate dental implant, natural bovine bone substitute materialstudy group: 8 immediate implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- medically free patients, good oral hygiene, no periapical lesions around teeth to be extracted
Key exclusion criteria (1 listed)
- patients with bone or soft tissue defects, poor oral hygiene, heavy smoking, bruxism, severe periodontal disease
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 dental implantcontrol group: 8 teeth were extracted then 8 immediate implants were placed without bone grafting | Combination product | control group |
| immediate dental implant, natural bovine bone substitute materialstudy group: 8 teeth were extracted then received 8 immediate implants followed by grafting with natural bovine bone substitute material with hyaluronic acid | Combination product | study group |
Primary outcome
Bone density
Time frame: baseline (immediately) and 6 months
using cone beam CT bone density was measured around the implant in housefield units immediately after implant placement and after 6 months.
implant stability
Time frame: Baseline (immediately) and after 4 months
using Osstell device, implant stability was measured immediately after implant placement and after 4 months
1 secondary outcome
Bone width
Time frame: Baseline (immediately) and 6 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 30 Sep 2025.
- Derived from this study: PubMed 42562852Foad MW, El Rawdy AM, Hamed MS. Clinical and radiographic evaluation of natural bovine bone with hyaluronic acid on osseointegration of immediate implants: a randomized clinical study. Sci Rep. 2026 Aug 6;16(1):24308. doi: 10.1038/s41598-026-64165-9.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Mohamed Said professor study director
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing immediate dental implant and immediate dental implant, natural bovine bone substitute material in people with Dental Implants, 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 1 inclusion and 1 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 30 Sep 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone density (time frame: baseline (immediately) and 6 months). The study lists 2 primary outcomes in all. 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 NCT07199725, which also lists 1 linked publication.
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 30 Sep 2025.