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Bone Graft
Sinus Augmentation for Dental Implants
N/A
Recruiting
Led By Lorenzo Mordini, DDS, MS
Research Sponsored by Tufts University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with full maxillary edentulism or Kennedy class I or III
Patients with two stage sinus augmentations with less than 5mm residual bone height in need of augmentation for implant placement
Must not have
Adults unable to consent (cognitively impaired adults)
Patients with a history of or current head and neck radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months from surgery
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to assess bone healing four months after a specific type of sinus augmentation procedure using a combination of autologous bone and xenograft, compared to using xenograft alone. The evaluation
Who is the study for?
This trial is for adults aged 18-100 who are patients at Tufts School of Dental Medicine, needing bone grafts for dental implants due to significant tooth loss. They must have a specific amount of residual bone height and not be pregnant, breastfeeding, or heavy smokers. Those with osteoporosis, prior sinus procedures, existing sinus issues, or conditions affecting bone metabolism can't join.
What is being tested?
The study tests the effectiveness of two types of bone healing after a sinus lift augmentation: one using a mix of the patient's own bone (autograft) with xenograft material versus using only xenograft material. The outcomes will be measured through radiographic analysis and tissue samples at four months post-procedure.
What are the potential side effects?
Potential side effects may include discomfort at the site where autologous bone is taken from, swelling or infection in the sinuses following augmentation, and possible adverse reactions to anesthesia used during these surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no upper teeth or missing teeth except for the front ones.
Select...
I need a sinus lift for dental implants due to having less than 5mm of bone height.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to make medical decisions due to cognitive impairment.
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I have had radiation therapy for head or neck cancer.
Select...
I currently smoke more than 10 cigarettes a day.
Select...
I lack my own tissue for a donor site.
Select...
I have a medical condition that affects my bone health.
Select...
I am willing to participate in the clinical trial.
Select...
I am under 18 years old.
Select...
I have been diagnosed with osteoporosis.
Select...
I have had a sinus lift surgery in the past.
Select...
I have existing sinus issues or issues found during sinus surgery.
Select...
I have had chemotherapy in the past or am currently undergoing it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months from surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months from surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Histological analysis
Secondary study objectives
Radiographic bone height gain at 4 months
Volumetric bone analysis 4 months post sinus augmentation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Xenograft - Autogenous 1:4Experimental Treatment2 Interventions
Sinus grafted with a ratio of Xenograft - Autogenous 1:4
Group II: Xenograft aloneActive Control2 Interventions
Sinus grafted with Xenograft only
Find a Location
Who is running the clinical trial?
Tufts UniversityLead Sponsor
270 Previous Clinical Trials
594,881 Total Patients Enrolled
Lorenzo Mordini, DDS, MSPrincipal InvestigatorTufts Univeristy