Clinical trial NCT06247098: Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone
Official title: Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Sinus Floor Augmentation
Dental Implant
Bone Substitute
Autogenous Bone Graft
Keywords: Histology
Volume measurements
Radiographic
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.


Eligibility criteria: Inclusion Criteria:

* Patients of Tufts School of Dental Medicine (TUSDM)
* Two stage sinus augmentations with \<5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
* Full maxillary edentulism or Kennedy class I or III
* 18 to 100 year old

Exclusion Criteria:

* Adults unable to consent (cognitively impaired adults)
* Those who self-report as pregnant or breastfeeding
* Wards of the state
* Non-Viable neonates
* Neonates of uncertain viability
* \< 18 years of age
* Refusal to participate
* Prior medical condition causing complications in bone metabolism
* Osteoporosis
* History of/or current chemotherapy
* History of/or current head and neck radiation
* Current heavy smoking \> 10 cigarettes/day
* Self-reported pregnancy or lactation
* Previous history of sinus elevation procedure
* Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
* Absence of autogenous donor site

Primary outcomes:
measure: Histological analysis
timeFrame: 4 months from surgery
Secondary outcomes:
measure: Volumetric bone analysis 4 months post sinus augmentation
timeFrame: 4 months from surgery
measure: Radiographic bone height gain at 4 months
timeFrame: 4 months post sinus augmentation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts Univeristy
name: Lorenzo Mordini, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Moraissi E, Alhajj WA, Al-Qadhi G, Christidis N. Bone Graft Osseous Changes After Maxillary Sinus Floor Augmentation: A Systematic Review. J Oral Implantol. 2022 Oct 1;48(5):464-471. doi: 10.1563/aaid-joi-D-21-00310.
citation: Al-Moraissi EA, Alkhutari AS, Abotaleb B, Altairi NH, Del Fabbro M. Do osteoconductive bone substitutes result in similar bone regeneration for maxillary sinus augmentation when compared to osteogenic and osteoinductive bone grafts? A systematic review and frequentist network meta-analysis. Int J Oral Maxillofac Surg. 2020 Jan;49(1):107-120. doi: 10.1016/j.ijom.2019.05.004. Epub 2019 Jun 21.
citation: Barone A, Crespi R, Aldini NN, Fini M, Giardino R, Covani U. Maxillary sinus augmentation: histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):519-25.