Peri-implant Bone and Soft TissuesPhase 4NCT07523412
Dimensional Changes of Peri-implant Tissues Following Jumping Gap Grafting Using Erythropoietin Gel Mixed With Xenograft.
A Phase 4 study testing Erythropoetin gel mixed with xenogenic bone graft and Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose) in people with Peri-implant Bone and Soft Tissues, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effect of Erythropoietin gel mixed with xenograft versus xenograft alone in grafting the jumping gap around immediate implant. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Peri-implant Bone and Soft Tissues
- What is being tested?
- Erythropoetin gel mixed with xenogenic bone graft and Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2026to 12 Nov 2026
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders aged from 20 to 50 years.
- Systemically free patients as evidenced by Burket's oral health history questionnaire.
- Patients need the extraction of non-restorable maxillary tooth in esthetic zone and the possibility of immediate placement of implants on the same site with Intact labial plate and interproximal bone levels (socket type 1).
- Gap space of more than 2 mm between the implant and buccal bone.
Who cannot join
- Smokers.
- Pregnant or lactating females.
- Acute infection at the implant site
- Patients under any medication that affects the healing.
- Vulnerable group of patients (prisoners, handicapped, and decisional impaired individuals).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dimensional Changes of Peri-implant Tissues Following Jumping Gap Grafting Using Erythropoietin Gel Mixed With Xenograft. (A Randomized Controlled Clinical Study)
This study will be conducted to compare the effect of Erythropoietin gel mixed with xenograft versus xenograft alone in grafting the jumping gap around immediate implant.
Read the detailed description
The distance between the implant and the defect's surrounding wall is known as the horizontal bone defect (also known as the "Jumping Distance" or "Gap"). By filling the space between the implant and the buccal bone walls of recently extracted sockets, bone grafting material promotes hard tissue repair and reduces marginal bone loss. To increase bone contact to the implant surface and lessen gingival recession brought on by horizontal bone resorption, bone grafting at the gap is advised.
Various methods have been employed to bridge the gap in bone: autograft and allograft-based bone substitutes, which can be utilized separately or in conjunction with other materials like freeze-dried bone, xenograft (like bovine bone), and ceramic-based bone graft alternatives like calcium phosphate, calcium sulphate, and bio-glass. According to a study by Bianchi S, using xenografts improved the osteoconductive qualities of bone regeneration by demonstrating significant cellular activity.
The potential of EPO to enhance bone growth and tissue protection by reducing ischemia and inflammatory responses is one of its non-hematopoietic properties. EPO stimulates the development of mesenchymal stem cells (MSCs) into osteoblasts and participates in the interactions of osteoblasts and osteoclasts to promote bone formation.
- Conditions
- Peri-implant Bone and Soft Tissues
- Being tested
- Erythropoetin gel mixed with xenogenic bone graft, Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)
- Keywords
- Radiographic assessment of alveolar bone width (0-6 months)., Radiographic assessment of alveolar bone height (0-6 months)., Clinical assessment (Soft tissue height and thickness): (0-3-6 months).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoetin gel mixed with xenogenic bone graftDrug
Patients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant.
Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)Other
Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant.
| Study group | Role | What they receive |
|---|---|---|
| Patients with EPO gel mixed with xenogenic bone graft | Experimental | Patients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant. Receives: Drug: Erythropoetin gel mixed with xenogenic bone graft |
| Patients with xenogenic bone graft and gelling agent | Active comparator | Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant. Receives: Other: Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment
Radiographic assessment of alveolar bone width by CBCT
Measured: 0-6 months
Secondary outcomes (2)
Radiographic assessment
Radiographic assessment of alveolar bone height by CBCT
Measured: 0-6 months
Clinical assessment
Clinical assessment (Soft tissue height and thickness)
Measured: 0-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start12 Apr 2026 (estimated)
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant Bone and Soft TissuesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed shaker ahmed taha, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523412
- Sponsor's protocol ID
- FDAsu-RecIM022439
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Changes of Peri-implant Tissues Following Jumping Gap Grafting Using Erythropoietin Gel Mixed With Xenograft. (A Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT07523412
- Acronym / sponsor ID
- FDAsu-RecIM022439
- Conditions
- Peri-implant Bone and Soft Tissues
- Keywords
- Radiographic assessment of alveolar bone width (0-6 months)., Radiographic assessment of alveolar bone height (0-6 months)., Clinical assessment (Soft tissue height and thickness): (0-3-6 months).
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Apr 2026 (estimated)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 13 Apr 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.
This study will be conducted to compare the effect of Erythropoietin gel mixed with xenograft versus xenograft alone in grafting the jumping gap around immediate implant.
Detailed description
The distance between the implant and the defect's surrounding wall is known as the horizontal bone defect (also known as the "Jumping Distance" or "Gap"). By filling the space between the implant and the buccal bone walls of recently extracted sockets, bone grafting material promotes hard tissue repair and reduces marginal bone loss. To increase bone contact to the implant surface and lessen gingival recession brought on by horizontal bone resorption, bone grafting at the gap is advised.
Various methods have been employed to bridge the gap in bone: autograft and allograft-based bone substitutes, which can be utilized separately or in conjunction with other materials like freeze-dried bone, xenograft (like bovine bone), and ceramic-based bone graft alternatives like calcium phosphate, calcium sulphate, and bio-glass. According to a study by Bianchi S, using xenografts improved the osteoconductive qualities of bone regeneration by demonstrating significant cellular activity.
The potential of EPO to enhance bone growth and tissue protection by reducing ischemia and inflammatory responses is one of its non-hematopoietic properties. EPO stimulates the development of mesenchymal stem cells (MSCs) into osteoblasts and participates in the interactions of osteoblasts and osteoclasts to promote bone formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with EPO gel mixed with xenogenic bone graft | Experimental | Drug: Erythropoetin gel mixed with xenogenic bone graftPatients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant. |
| Patients with xenogenic bone graft and gelling agent | Active comparator | Other: Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders aged from 20 to 50 years.
- Systemically free patients as evidenced by Burket's oral health history questionnaire.
- Patients need the extraction of non-restorable maxillary tooth in esthetic zone and the possibility of immediate placement of implants on the same site with Intact labial plate and interproximal bone levels (socket type 1).
- Gap space of more than 2 mm between the implant and buccal bone.
Key exclusion criteria (5 listed)
- Smokers.
- Pregnant or lactating females.
- Acute infection at the implant site
- Patients under any medication that affects the healing.
- Vulnerable group of patients (prisoners, handicapped, and decisional impaired individuals).
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 |
|---|---|---|
| Erythropoetin gel mixed with xenogenic bone graftPatients with EPO gel mixed with xenogenic bone graft in the jumping gap of immediate implant. | Drug | Patients with EPO gel mixed with xenogenic bone graft |
| Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose)Patients with xenogenic bone graft and gelling agent in the jumping gap of immediate implant. | Other | Patients with xenogenic bone graft and gelling agent |
Primary outcome
Radiographic assessment
Time frame: 0-6 months
Radiographic assessment of alveolar bone width by CBCT
2 secondary outcomes
Radiographic assessment
Time frame: 0-6 months
Clinical assessment
Time frame: 0-3-6 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 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Peri-implant Bone and Soft Tissues
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Not yet recruiting
Sandwich vs. Mixed Bone Augmentation for Implant Placement
Peri-implant Bone and Soft Tissues
Active, not recruiting
Clinical Assessment of UV Photofunctionalization on Stability and Osseointegration of Early Loaded Implants
Evaluating the Clinical Efficacy of Applying Ultraviolet Photofunctionalization (UV phF) to Standard Titanium Implants Immediately Before Surgery, Monitoring Early Implant Stability and Osseointegration During the Critical Initial Healing Phase
Active, not recruiting
Implant Placement Depth and Peri-Implant Tissue Outcomes
Dental Implant Placement, Soft Tissue Management in Subcrestal Dental Implants
Recruiting
Impact of Abutment Screw Torque on Marginal Bone Loss
Soft Tissues According to the Abutment Torque, Microleakage Accordint to the Abutment Torque
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 Phase 4 study testing Erythropoetin gel mixed with xenogenic bone graft and Xenogenic bone with gelling aget CMC ( carboxymethyl cellulose) in people with Peri-implant Bone and Soft Tissues, run by Ain Shams 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 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: opening soon, as of the sponsor's last update on 15 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed S Ahmed (+20 1211380626, AhmedShakerTaha@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment (time frame: 0-6 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 15 Apr 2026.