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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Maxillary Sinus Floor Augmentation Dental Implant Bone Substitute Autogenous Bone Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Clinical examiners, study surgeons, and subjects will not be blinded. Analysis of histomorphometric, histologic, and volumetric data will be completed by an external lab and will not be aware of what group the subjects were in.

Study Groups

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Xenograft - Autogenous 1:4

Sinus grafted with a ratio of Xenograft - Autogenous 1:4

Group Type EXPERIMENTAL

Sinus Lift augmentation

Intervention Type PROCEDURE

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

Cone-beam computed tomography systems (CBCT)

Intervention Type DEVICE

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

Xenograft alone

Sinus grafted with Xenograft only

Group Type ACTIVE_COMPARATOR

Sinus Lift augmentation

Intervention Type PROCEDURE

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

Cone-beam computed tomography systems (CBCT)

Intervention Type DEVICE

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

Interventions

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Sinus Lift augmentation

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

Intervention Type PROCEDURE

Cone-beam computed tomography systems (CBCT)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No