Hopeless TeethNCT06601400
Xenograft with or Without Erythropoietin in Immediate Dental Implant
A study testing Erythropoietin (EPO) with xenograft and Xenograft alone in people with Hopeless Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hopeless Teeth
- What is being tested?
- Erythropoietin (EPO) with xenograft and Xenograft alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2024to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years) with non-restorable maxillary teeth in the esthetic zone (upper right second premolar to upper left second premolar).
- Intact with thin labial plate of bone (≤1mm).
- The recipient site of the implant should be free from any pathological conditions.
- Patients who are cooperative, motivated and hygiene conscious.
- Appropriate crown height space to maintain favorable crown : implant ratio
Who cannot join
- Systemic conditions/diseases that contraindicate surgery.
- Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
- Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
- Patients with periodontal disease.
- Alcohol or drug abuse.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, Cairo university
Giza
Cairo University, (+202)23634965, dentmail@dentistry.cu.edu.eg
kholoud Sobhy Eldeeb, Master degree holder
About this study
Official title: Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized Clinical Trial
The aim of this study is to evaluate changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone
Read the detailed description
PICO:
Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.
Control: Immediate implant placement with Xenograft alone.
- Conditions
- Hopeless Teeth
- Being tested
- Erythropoietin (EPO) with xenograft, Xenograft alone
- Keywords
- dental implant, Erythropoietin, Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin (EPO) with xenograftCombination product
After atraumatic extraction of the non-restorable tooth, Implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft and erythropoietin.
Xenograft aloneOther
After atraumatic extraction of the non-restorable tooth, implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft alone.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Test) | Experimental | Immediate implant placement with Xenograft mixed with Erythropoietin Receives: Combination Product: Erythropoietin (EPO) with xenograft |
| Group B (Control) | Active comparator | Immediate implant placement with Xenograft alone Receives: Other: Xenograft alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone thickness.
by Cone Beam Computed Tomography (CBCT) in mm
Measured: 1 year follow up period
Secondary outcomes (7)
Crestal bone loss
will be measured by Cone Beam Computed Tomography (CBCT) in mm
Measured: 1 year follow up period
Soft tissue thickness.
will be measured by Endodontic spreader with rubber stopper in mm
Measured: 1 year follow up period
The pink esthetic score (PES)
by taking photographs
Measured: 1 year follow up period
Success and survival criteria
the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as failure if it can\'t reach any one of the success criteria
Measured: 1 year follow up period
Bleeding on probing (BOP)
According to presence (yes) or absence (No) of bleeding on probing
Measured: 1 year follow up period
Pain score
by using Visual analogue scale from (0-10)
Measured: 1, 3, and 7 days
Full-mouth plaque score
According to presence (yes) or absence(No) of plaque
Measured: 1 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Sep 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (estimated)
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 Hopeless TeethStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud Sobhy Ibrahim Farag El Deeb, Cairo University
- Investigators
- Noha ghallab, PHD, Study director, Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.Manar El Zanaty, PHD, Study chair, lecturer of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601400
- Sponsor's protocol ID
- Erythropoietin,Dental implant
- Status last verified
- Sep 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fettouh AIA, Ghallab NA, Ghaffar KA, Mina NA, Abdelmalak MS, Abdelrahman AAG, Shemais NM. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res. 2023 Apr;25(2):271-283. doi: 10.1111/cid.13178. Epub 2023 Jan 3.
PubMed 36596471
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Dimensional Changes After Using Xenograft with or Without Erythropoietin Around Immediate Implants in the Esthetic Zone: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06601400
- Acronym / sponsor ID
- Erythropoietin,Dental implant
- Conditions
- Hopeless Teeth
- Keywords
- dental implant, Erythropoietin, Xenograft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Sep 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (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 changes in buccal bone thickness after immediate implant placement with xenograft mixed with erythropoietin in the anterior maxilla with a thin buccal bone
Detailed description
PICO:
Population: Patients with non-restorable tooth in anterior maxilla with thin buccal bone (less than 1mm) Intervention: Immediate implant placement with Xenograft mixed with Erythropoietin.
Control: Immediate implant placement with Xenograft alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Test) | Experimental | Combination Product: Erythropoietin (EPO) with xenograftImmediate implant placement with Xenograft mixed with Erythropoietin |
| Group B (Control) | Active comparator | Other: Xenograft aloneImmediate implant placement with Xenograft alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Erythropoietin (EPO) with xenograftAfter atraumatic extraction of the non-restorable tooth, Implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft and erythropoietin. | Combination product | Group A (Test) |
| Xenograft aloneAfter atraumatic extraction of the non-restorable tooth, implant will be placed palatal and apical to osteotomy with at least 2mm gap junction between implant and buccal bone which will be grafted with xenograft alone. | Other | Group B (Control) |
Primary outcome
Buccal bone thickness.
Time frame: 1 year follow up period
by Cone Beam Computed Tomography (CBCT) in mm
7 secondary outcomes
Crestal bone loss
Time frame: 1 year follow up period
Soft tissue thickness.
Time frame: 1 year follow up period
The pink esthetic score (PES)
Time frame: 1 year follow up period
Success and survival criteria
Time frame: 1 year follow up period
Bleeding on probing (BOP)
Time frame: 1 year follow up period
Pain score
Time frame: 1, 3, and 7 days
Full-mouth plaque score
Time frame: 1 year follow up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36596471Fettouh AIA, Ghallab NA, Ghaffar KA, Mina NA, Abdelmalak MS, Abdelrahman AAG, Shemais NM. Bone dimensional changes after flapless immediate implant placement with and without bone grafting: Randomized clinical trial. Clin Implant Dent Relat Res. 2023 Apr;25(2):271-283. doi: 10.1111/cid.13178. Epub 2023 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Hopeless Teeth
Enrolling by invitation
Peri-implant Tissue Changes Using Dual Zone Concept With Connective Tissue Graft Versus Concentrated Growth Factor
Hopeless Tooth in Esthetic Zone, Loss of Soft and Hard Tissue Around Implant
Active, not recruiting
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
Periodontitis
Recruiting
To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.
Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth
Enrolling by invitation
Immediate Dental Implant Installation With and Without Socket Shield Technique in Aesthetic Zone
Immediate Dental Implants, Thin Labial Plate of Bone Pre-extraction
Recruiting
Performance of Next-X in Alveolar Ridge Preservation
Hopeless Tooth
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.
Noha ghallab, PHD study director
Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.
Manar El Zanaty, PHD study chair
lecturer of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythropoietin (EPO) with xenograft and Xenograft alone in people with Hopeless Teeth, 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 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kholoud El Deeb, Master degree holder ((+20)1113211914, kholoud.eldeeb@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal bone thickness. (time frame: 1 year follow up period). 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 NCT06601400, 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 19 Sep 2024.