Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation (sinus)
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Ramy H El Shater, MDS
- Phone Number: +201014111431
- Email: ramy.hamdy@miuegypt.edu.eg
Study Locations
-
-
-
Ismailia, Egypt
- Recruiting
- Suez Canal University
-
Contact:
- Mohamed El Sholqamy, Professor
- Phone Number: 00201014111431
- Email: ramy.hamdy@miuegypt.edu.eg
-
Contact:
- Ramy El Shater, Assistant Lecturer
- Phone Number: 00201014111431
-
-
Ismailia Governorate
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Ismailia, Ismailia Governorate, Egypt, 41522
- Recruiting
- Suez Canal University
-
Contact:
- El Sholqamy, Professor
- Phone Number: +20643205208
- Email: president_office@suez.edu.eg
-
Contact:
- Ramy, Assistant Lecturer
- Phone Number: +201014111431
- Email: ramy.hamdy@miuegypt.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
maxillary sinus membrane is elevated through a lateral window and held in place with screws buccopalatally, similar to tenting.
|
graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting.
Other Names:
|
|
Experimental: study group
enhanced xenograft will be used to augment the maxillary sinus floor
|
hydrogel-enhanced xenograft
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone height gain
Time Frame: 8 months
|
radiographically, through CBCT
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient centered edema measurement
Time Frame: 0-7 days
|
linear measurements between specific reference points on the face
|
0-7 days
|
|
patient reported/related edema estimate
Time Frame: 3-7 days
|
patients' assessment of swelling according to visual scale for edema
|
3-7 days
|
|
VAS pain
Time Frame: 10 days
|
patients' assessment of pain 0-10 daily
|
10 days
|
|
bone structure
Time Frame: 8 months
|
histological examination of harvested bone under microscope
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/ 939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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