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OpenTrials
Active, Not Recruiting

NCT Number: NCT06247098

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Maxillary Sinus Floor Augmentation Autogenous Bone Graft Bone Substitute Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinus Lift augmentation

Procedure

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

Cone-beam computed tomography systems (CBCT)

Device

An research only use of CBCT at visit 2 to review healing status.

Primary outcomes

  1. Histological analysis

    Time frame: 4 months from surgery

    Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate

Secondary outcomes

  1. Volumetric bone analysis 4 months post sinus augmentation

    Time frame: 4 months from surgery

    Sinus volume calculation via CBCT analysis

  2. Radiographic bone height gain at 4 months

    Time frame: 4 months post sinus augmentation

    Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 7, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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