Bone Loss, AlveolarNCT06653868
Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts
A study testing Immediate dental implant with filling the peri implant gap with xenogenic sticky bone in people with Bone Loss, Alveolar, run by Cairo University at 1 site in Egypt.
Trial summary
In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts? Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- Immediate dental implant with filling the peri implant gap with xenogenic sticky bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2024to 15 Mar 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with healthy systemic condition (Mazzotti et al., 2023).
- Age from 20-50 years old
- Patients must be free of any systemic disease which could influence the surgical procedure.
- Tooth involved in the esthetic zone.
- Sufficient hard and soft tissue volume in vertical and buccolingual direction
- Natural teeth adjacent to the involved tooth will be required to be free from infection.
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- Controlled oral hygiene.
- Indication for tooth extraction included (Degidi et al., 2012);
- Endodontic failures
- Untreatable caries
- Non- restorable teeth
- Vertical root fracture
- Remaining roots
Who cannot join
- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
- 5.Presence of acute dento-alveolar infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial
In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?
Read the detailed description
The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.
- Conditions
- Bone Loss, Alveolar
- Being tested
- Immediate dental implant with filling the peri implant gap with xenogenic sticky bone
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implant with filling the peri implant gap with xenogenic sticky boneProcedure or surgery
Also called gap distance augmentation
gap distance augmentation with bone graft
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement surgery with filling the gap distance with alloplastic sticky graft | Experimental | immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast. Receives: Procedure: Immediate dental implant with filling the peri implant gap with xenogenic sticky bone |
| immediate implant placement surgery with filling the gap distance with xenogenic sticky bone | Experimental | immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft. Receives: Procedure: Immediate dental implant with filling the peri implant gap with xenogenic sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone changes
superimposition
Measured: 6 months
Secondary outcomes (1)
pink esthetic score (0-14)
soft tissue esthetics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Oct 2024
- Primary completion20 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bassant mohye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653868
- Sponsor's protocol ID
- per631
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06653868
- Acronym / sponsor ID
- per631
- Conditions
- Bone Loss, Alveolar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 22 Oct 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.
In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?
Detailed description
The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement surgery with filling the gap distance with alloplastic sticky graft | Experimental | Procedure: Immediate dental implant with filling the peri implant gap with xenogenic sticky boneimmediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast. |
| immediate implant placement surgery with filling the gap distance with xenogenic sticky bone | Experimental | Procedure: Immediate dental implant with filling the peri implant gap with xenogenic sticky boneimmediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patients with healthy systemic condition (Mazzotti et al., 2023).
- Age from 20-50 years old
- Patients must be free of any systemic disease which could influence the surgical procedure.
- Tooth involved in the esthetic zone.
- Sufficient hard and soft tissue volume in vertical and buccolingual direction
Key exclusion criteria (2 listed)
- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.
- 5.Presence of acute dento-alveolar infection.
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 implant with filling the peri implant gap with xenogenic sticky boneAlso: gap distance augmentationgap distance augmentation with bone graft | Procedure or surgery | immediate implant placement surgery with filling the gap distance with alloplastic sticky graft, immediate implant placement surgery with filling the gap distance with xenogenic sticky bone |
Primary outcome
bone changes
Time frame: 6 months
superimposition
1 secondary outcome
pink esthetic score (0-14)
Time frame: 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 21 Oct 2026.
- 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. 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 study testing Immediate dental implant with filling the peri implant gap with xenogenic sticky bone in people with Bone Loss, Alveolar, 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 13 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 21 Oct 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.
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 changes (time frame: 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 21 Oct 2026.