Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone

Dental Implant Clinical Trial

Official title:

Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247098
• Other study ID #: STUDY00004629
• Status: Recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: May 2028

Study information

• Verified date: June 2024
• Source: Tufts University
• Contact: Lorenzo Mordini, DDS, MS
• Phone: 6176366888
• Email: lorenzo.mordini[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2028
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Substitute
• Dental Implant
• Maxillary Sinus Floor Augmentation

Intervention

Procedure:
• Sinus Lift augmentation
Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control)

Device:
• Cone-beam computed tomography systems (CBCT)
An research only use of CBCT at visit 2 to review healing status.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological analysis	Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate	4 months from surgery
Secondary	Volumetric bone analysis 4 months post sinus augmentation	Sinus volume calculation via CBCT analysis	4 months from surgery
Secondary	Radiographic bone height gain at 4 months	Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption	4 months post sinus augmentation