Immediate Implant Placement in Chronic Infected SocketPhase 1RCTNCT07784075
Efficacy of Mixture of Vancomycin With Xenograft for Immediate Implant Placement in Chronic Infected Socket
A Phase 1 study testing immediate dental implants Placement in Chronic Infected Socket in people with Immediate Implant Placement in Chronic Infected Socket, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Adding local vancomycin to xenografts greatly benefits stability, bone density, and limits marginal bone loss in dental implants in infected socket. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant Placement in Chronic Infected Socket
- What is being tested?
- immediate dental implants Placement in Chronic Infected Socket
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 1 Apr 2025
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a badly decayed, hopeless tooth with periapical infection indicated for extraction and seeking implant placement
Who cannot join
- Acute infected socket.
- Any socket with more than four wall defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Mixture of Vancomycin With Xenograft for Immediate Implant Placement in Chronic Infected Socket (Clinical and Radiographic Study)
Adding local vancomycin to xenografts greatly benefits stability, bone density, and limits marginal bone loss in dental implants in infected socket.
Read the detailed description
Aim: to evaluate how adding vancomycin to the xenograft in the infected socket affects bone preservation during immediate implant placement.
Background: Proper dental implant placement is crucial for successful osseointegration, as the resultant tiny gaps between the implant and bone can affect implant stability. These gaps are better filled with xenografts, which are easy to handle, widely available, and provide an osteoconductive framework that supports better implant outcomes. It's also important to prevent nearby infections, since the infected socket can damage both soft and hard tissues, raising the risk of peri-implantitis and further implant failure. Applying locally delivered antibiotics during placement can help protect and manage against early infections.
Patients and methods: Twenty patients with mandibular extraction sockets participated in the study divided into two groups: 10 patients received a xenograft mixed with vancomycin (Group I), and 10 patients received a xenograft alone (Group II). Implant stability was assessed clinically at baseline and at 6 months only, while CBCT scans were used to monitor crestal bone loss and bone density at baseline, 6 months, and 9 months. Post-surgical complications were also monitored throughout the study period.
- Being tested
- immediate dental implants Placement in Chronic Infected Socket
- Keywords
- Immediate dental implant, Infected Socket, Bone preservation,, Xenograft,, Vancomycin., Local delivery antibiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate dental implants Placement in Chronic Infected SocketProcedure or surgery
(Clinical and Radiographic Study)
| Study group | Role | What they receive |
|---|---|---|
| Xenograft plus vancomycin (Gp I) | Experimental | immediate dental implants with a mixture of xenograft and vancomycin. Receives: Procedure: immediate dental implants Placement in Chronic Infected Socket |
| Xenograft only (Gp II) | Placebo comparator | immediate dental implants with xenograft only. Receives: Procedure: immediate dental implants Placement in Chronic Infected Socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
Changes in ISQ utilizing the Ostell ™ system
Measured: baseline, 1, 6 months after implant placement
Secondary outcomes (2)
bone marginal level
Radiographic evaluation: Marginal bone height at the mesial and distal surfaces was measured in the panoramic view of the CBCT software, while the buccal and palatal surfaces were assessed in the cross-sectional view.
Measured: baseline, 1, 6 and 9 months after treatment
measure bone density
Radiographic evaluation,using CBCT software, the average density of the marginal and crestal bone around the implant was measured
Measured: baseline, 1, 6 and 9 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start10 Jul 2024
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate Implant Placement in Chronic Infected SocketStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical and Radiographic Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Hussein Rafat Kotb, Sphinx university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784075
- Sponsor's protocol ID
- AUARC20240007-10
- Other IDs
- AUARC20240007-10
- Acronym
- RCT
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mixture of Vancomycin With Xenograft for Immediate Implant Placement in Chronic Infected Socket (Clinical and Radiographic Study)
- ClinicalTrials.gov ID
- NCT07784075
- Acronym / sponsor ID
- RCT / AUARC20240007-10
- Keywords
- Immediate dental implant, Infected Socket, Bone preservation,, Xenograft,, Vancomycin., Local delivery antibiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 25 Aug 2026 (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.
Adding local vancomycin to xenografts greatly benefits stability, bone density, and limits marginal bone loss in dental implants in infected socket.
Detailed description
Aim: to evaluate how adding vancomycin to the xenograft in the infected socket affects bone preservation during immediate implant placement.
Background: Proper dental implant placement is crucial for successful osseointegration, as the resultant tiny gaps between the implant and bone can affect implant stability. These gaps are better filled with xenografts, which are easy to handle, widely available, and provide an osteoconductive framework that supports better implant outcomes. It's also important to prevent nearby infections, since the infected socket can damage both soft and hard tissues, raising the risk of peri-implantitis and further implant failure. Applying locally delivered antibiotics during placement can help protect and manage against early infections.
Patients and methods: Twenty patients with mandibular extraction sockets participated in the study divided into two groups: 10 patients received a xenograft mixed with vancomycin (Group I), and 10 patients received a xenograft alone (Group II). Implant stability was assessed clinically at baseline and at 6 months only, while CBCT scans were used to monitor crestal bone loss and bone density at baseline, 6 months, and 9 months. Post-surgical complications were also monitored throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinical and Radiographic Study
| Arm | Type | Receives |
|---|---|---|
| Xenograft plus vancomycin (Gp I) | Experimental | Procedure: immediate dental implants Placement in Chronic Infected Socketimmediate dental implants with a mixture of xenograft and vancomycin. |
| Xenograft only (Gp II) | Placebo comparator | Procedure: immediate dental implants Placement in Chronic Infected Socketimmediate dental implants with xenograft only. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- a badly decayed, hopeless tooth with periapical infection indicated for extraction and seeking implant placement
Key exclusion criteria (2 listed)
- Acute infected socket.
- Any socket with more than four wall defects.
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 implants Placement in Chronic Infected Socket(Clinical and Radiographic Study) | Procedure or surgery | Xenograft only (Gp II), Xenograft plus vancomycin (Gp I) |
Primary outcome
implant stability
Time frame: baseline, 1, 6 months after implant placement
Changes in ISQ utilizing the Ostell ™ system
2 secondary outcomes
bone marginal level
Time frame: baseline, 1, 6 and 9 months after treatment
measure bone density
Time frame: baseline, 1, 6 and 9 months after treatment
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 25 Aug 2026.
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 Phase 1 study testing immediate dental implants Placement in Chronic Infected Socket in people with Immediate Implant Placement in Chronic Infected Socket, run by Al-Azhar 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 2 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 25 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
implant stability (time frame: baseline, 1, 6 months after 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 25 Aug 2026.