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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation

Clinical, Radiographic and Histologic Assessment of a New Xenograft Enhanced With Hydrogel in Augmentation of the Maxillary Sinus: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07737704
Acronym
sinus
Enrollment
30
Registered
2026-07-30
Start date
2026-08-10
Completion date
2027-12-12
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation, Bone Augmentation

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.

Brief 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. 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.

Interventions

BIOLOGICALXenograft

hydrogel-enhanced xenograft

OTHERmaxillary sinus membrane elevation and stabilization.

graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting.

Sponsors

Misr International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
bone height gain8 monthsradiographically, through CBCT

Secondary

MeasureTime frameDescription
patient centered edema measurement0-7 dayslinear measurements between specific reference points on the face
patient reported/related edema estimate3-7 dayspatients' assessment of swelling according to visual scale for edema
VAS pain10 dayspatients' assessment of pain 0-10 daily
bone structure8 monthshistological examination of harvested bone under microscope

Countries

Egypt

Contacts

CONTACTRamy H El Shater, MDS
ramy.hamdy@miuegypt.edu.eg+201014111431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026