Maxillary Sinus Floor AugmentationPhase 2/3sinusNCT07737704
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
A Phase 2/3 study testing Xenograft and maxillary sinus membrane elevation and stabilization. in people with Maxillary Sinus Floor Augmentation and Maxillary Sinus Elevation, run by Misr International University at 3 sites in Egypt.
Trial summary
Implant supported dental restorations are sometimes challenging with decreased bone height in the posterior maxilla. The goal of this study is to test an augmentation bone substitute in elevating the maxillary sinus floor; in terms of soft tissue reaction, formed bone height as well as structure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation, Bone Augmentation
- What is being tested?
- Xenograft and maxillary sinus membrane elevation and stabilization.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesEgypt
- Study dates
- 10 Aug 2026to 12 Dec 2027
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male/female patients above the age of 18.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic posterior maxilla.
- Alveolar bone height less than 5 mm at the defective site.
- Good oral hygiene.
- Patient's consensual agreement to be enrolled in the study.
Who cannot join
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollement.
- (Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Suez Canal University
Ismailia, Ismailia Governorate, 41522
El Sholqamy, Professor, +20643205208, president_office@suez.edu.eg
Ramy, Assistant Lecturer, +201014111431, ramy.hamdy@miuegypt.edu.eg
- Recruiting
Suez Canal University
Ismailia
Head of Oral & Maxillofacial Surgery, +20643205208, president_office@suez.edu.eg
Assistant Lecturer, +201014111431, ramy.hamdy@miuegypt.edu.eg
- Recruiting
Suez Canal University
Ismailia
Mohamed El Sholqamy, Professor, 00201014111431, ramy.hamdy@miuegypt.edu.eg
Ramy El Shater, Assistant Lecturer, 00201014111431
About this study
Official title: Clinical, Radiographic and Histologic Assessment of a New Xenograft Enhanced With Hydrogel in Augmentation of the Maxillary Sinus: A Randomized Controlled Trial
Implant supported dental restorations are sometimes challenging with decreased bone height in the posterior maxilla. The goal of this study is to test an augmentation bone substitute in elevating the maxillary sinus floor; in terms of soft tissue reaction, formed bone height as well as structure.
Bone substitute will be compared to a graftless method of bone augmentation depending on participants' bodies forming bone in the defective area.
Read more
Participants will:
- Undergo lateral maxillary sinus floor elevation with bone substitute or graftless method.
- Record postoperative swelling and pain through the follow up period.
- Take radiographs for evaluation of the formed bone before placing dental implants.
Read the detailed description
Severe atrophy of the posterior maxilla is challenging when implant supported restorations are needed. This occurs with advanced bone loss following long standing extractions along with maxillary sinus pneumatisation leading to inadequate bone height to receive a dental implant. A variety of approaches of whether to use short implants, augment the defective site along with placing an implant or even a staged approach where the atrophic site is augmented as a primary stage followed by implant placement as a secondary stage -in cases of severe atrophy- are suggested. Different techniques, as well as materials, have been proposed for augmentation of the atrophic bone to receive an endosseous implant. To date, they are both subject to continuous modifications.
Aim is to assess a novel hydrogel-enhanced xenograft material; clinically, radiographically and histologically in lateral window maxillary sinus floor elevation in a staged augmentation approach. Null hypothesis suggests that there is no significant difference between using hydrogel-enhanced xenograft material in comparison with graftless augmentation of the maxillary sinus floor in terms of tissue reaction, formed bone quantity and quality. Whereas, the alternative hypothesis claims favourability of the hydrogel-enhanced xenograft over graftless augmentation of the maxillary sinus floor.
Thirty posterior maxillary edentulous sites requiring open sinus augmentation for staged dental implant placement will be studied. Patients will be randomly allocated into two groups. Group 1 (study group) will receive a xenograft enhanced with hydrogel after Shneiderian membrane elevation. Group 2 (control group) will have stainless steel screws/pins placed buccopalatally to maintain the elevated membrane and stabilize the formed blood clot as graftless augmentation. Surgeries will be evaluated clinically in terms of pain, edema and tissue response during the follow up period. Radiographic assessment will be performed during the surgical follow-up period and after 8 months; to evaluate the formed bone height and density using CBCT. After 8 months a cylindrical bone core using a trephine bur will be taken from the augmented site, this osteotomy will be further prepared to receive the implant. Bone cores from both groups will be examined histologically.
- Being tested
- Xenograft, maxillary sinus membrane elevation and stabilization.
- Keywords
- maxillary sinus pneumatization., severe posterior maxillary ridge atrophy., inadequate residual bone height., open sinus augmentation., lateral maxillary sinus floor elevation., tenting of the Schneiderian membrane., staged maxillary sinus floor augmentation and implant placement., modified xenografts., graftless augmentation., bone augmentation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenograftBiological
Also called bone augmentation., xenograft augmentation., maxillary sinus floor augmentation.
hydrogel-enhanced xenograft
maxillary sinus membrane elevation and stabilization.Other
Also called graftless augmentation., tenting.
graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | maxillary sinus membrane is elevated through a lateral window and held in place with screws buccopalatally, similar to tenting. Receives: Other: maxillary sinus membrane elevation and stabilization. |
| study group | Experimental | enhanced xenograft will be used to augment the maxillary sinus floor Receives: Biological: Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height gain
radiographically, through CBCT
Measured: 8 months
Secondary outcomes (4)
patient centered edema measurement
linear measurements between specific reference points on the face
Measured: 0-7 days
patient reported/related edema estimate
patients' assessment of swelling according to visual scale for edema
Measured: 3-7 days
VAS pain
patients' assessment of pain 0-10 daily
Measured: 10 days
bone structure
histological examination of harvested bone under microscope
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Jun 2027 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus Floor AugmentationStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Hamdy Seif El Nasr El Shater, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737704
- Sponsor's protocol ID
- 2025/ 939
- Acronym
- sinus
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histologic Assessment of a New Xenograft Enhanced With Hydrogel in Augmentation of the Maxillary Sinus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07737704
- Acronym / sponsor ID
- sinus / 2025/ 939
- Keywords
- maxillary sinus pneumatization., severe posterior maxillary ridge atrophy., inadequate residual bone height., open sinus augmentation., lateral maxillary sinus floor elevation., tenting of the Schneiderian membrane., staged maxillary sinus floor augmentation and implant placement., modified xenografts.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 30 Jul 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.
Implant supported dental restorations are sometimes challenging with decreased bone height in the posterior maxilla. The goal of this study is to test an augmentation bone substitute in elevating the maxillary sinus floor; in terms of soft tissue reaction, formed bone height as well as structure.
Bone substitute will be compared to a graftless method of bone augmentation depending on participants' bodies forming bone in the defective area.
Participants will:
- Undergo lateral maxillary sinus floor elevation with bone substitute or graftless method.
- Record postoperative swelling and pain through the follow up period.
- Take radiographs for evaluation of the formed bone before placing dental implants.
Detailed description
Severe atrophy of the posterior maxilla is challenging when implant supported restorations are needed. This occurs with advanced bone loss following long standing extractions along with maxillary sinus pneumatisation leading to inadequate bone height to receive a dental implant. A variety of approaches of whether to use short implants, augment the defective site along with placing an implant or even a staged approach where the atrophic site is augmented as a primary stage followed by implant placement as a secondary stage -in cases of severe atrophy- are suggested. Different techniques, as well as materials, have been proposed for augmentation of the atrophic bone to receive an endosseous implant. To date, they are both subject to continuous modifications.
Aim is to assess a novel hydrogel-enhanced xenograft material; clinically, radiographically and histologically in lateral window maxillary sinus floor elevation in a staged augmentation approach. Null hypothesis suggests that there is no significant difference between using hydrogel-enhanced xenograft material in comparison with graftless augmentation of the maxillary sinus floor in terms of tissue reaction, formed bone quantity and quality. Whereas, the alternative hypothesis claims favourability of the hydrogel-enhanced xenograft over graftless augmentation of the maxillary sinus floor.
Thirty posterior maxillary edentulous sites requiring open sinus augmentation for staged dental implant placement will be studied. Patients will be randomly allocated into two groups. Group 1 (study group) will receive a xenograft enhanced with hydrogel after Shneiderian membrane elevation. Group 2 (control group) will have stainless steel screws/pins placed buccopalatally to maintain the elevated membrane and stabilize the formed blood clot as graftless augmentation. Surgeries will be evaluated clinically in terms of pain, edema and tissue response during the follow up period. Radiographic assessment will be performed during the surgical follow-up period and after 8 months; to evaluate the formed bone height and density using CBCT. After 8 months a cylindrical bone core using a trephine bur will be taken from the augmented site, this osteotomy will be further prepared to receive the implant. Bone cores from both groups will be examined histologically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: maxillary sinus membrane elevation and stabilization.maxillary sinus membrane is elevated through a lateral window and held in place with screws buccopalatally, similar to tenting. |
| study group | Experimental | Biological: Xenograftenhanced xenograft will be used to augment the maxillary sinus floor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male/female patients above the age of 18.
- Patients with one or more teeth requiring implant supported dental restoration in atrophic posterior maxilla.
- Alveolar bone height less than 5 mm at the defective site.
- Good oral hygiene.
- Patient's consensual agreement to be enrolled in the study.
Key exclusion criteria (5 listed)
- Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
- Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
- Heavy smokers.
- Patients not indicated for an implant supported restoration at the time of enrollement.
- (Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).
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 |
|---|---|---|
| XenograftAlso: bone augmentation., xenograft augmentation., maxillary sinus floor augmentation.hydrogel-enhanced xenograft | Biological | study group |
| maxillary sinus membrane elevation and stabilization.Also: graftless augmentation., tenting.graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting. | Other | control group |
Primary outcome
bone height gain
Time frame: 8 months
radiographically, through CBCT
4 secondary outcomes
patient centered edema measurement
Time frame: 0-7 days
patient reported/related edema estimate
Time frame: 3-7 days
VAS pain
Time frame: 10 days
bone structure
Time frame: 8 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 30 Jul 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.
3 sites 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 Xenograft and maxillary sinus membrane elevation and stabilization. in people with Maxillary Sinus Floor Augmentation and Maxillary Sinus Elevation, run by Misr International University at 3 sites 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 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Ramy H El Shater, MDS (+201014111431, ramy.hamdy@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone height gain (time frame: 8 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 30 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.