Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation

NCT07737704 | Recruiting Phase 2

• 1 other identifier: 2025/ 939
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

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.

Outcome Measures

Primary Outcomes (1)

• bone height gain

  radiographically, through CBCT

  8 months

Secondary Outcomes (4)

• patient centered edema measurement

  0-7 days

• patient reported/related edema estimate

  3-7 days

• VAS pain

  10 days

• bone structure

  8 months

Study Arms (2)

control group

ACTIVE COMPARATOR

maxillary sinus membrane is elevated through a lateral window and held in place with screws buccopalatally, similar to tenting.

Other: maxillary sinus membrane elevation and stabilization.

study group

EXPERIMENTAL

enhanced xenograft will be used to augment the maxillary sinus floor

Biological: Xenograft

Interventions

Xenograft BIOLOGICAL

hydrogel-enhanced xenograft

Also known as: bone augmentation., xenograft augmentation., maxillary sinus floor augmentation.

study group

maxillary sinus membrane elevation and stabilization. OTHER

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

Also known as: graftless augmentation., tenting.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Misr International University: lead

Study Sites (3)

Suez Canal University

Ismailia, Ismailia Governorate, 41522, Egypt

RECRUITING

Suez Canal University

Ismailia, Egypt

RECRUITING

Suez Canal University

Ismailia, Egypt

RECRUITING

MeSH Terms

Interventions

Transplantation, Heterologous; Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Oral Surgical Procedures; Bone Transplantation; Orthopedic Procedures; Dentistry

Central Study Contacts

Ramy H El Shater, MDS

CONTACT

+201014111431; ramy.hamdy@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

EG (3)