Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOhio State University
About this trial
This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication of bilateral sinus augmentation through lateral window technique to prepare maxillary right and left posterior edentulous sites for a single or multiple unit implant supported restorations.
Systemically healthy with controlled conditions
Periodontally healthy/controlled dentition
No known chronic and/or seasonal sinusitis
Disqualifiers
1. Indication of sinus augmentation through indirect techniques (≥5 mm initial alveolar ridge height from crest to maxillary sinus floor)
Implant placement surgery planned somewhere else
Implant placement planned at the time of sinus augmentation
Cases requiring major alveolar ridge augmentation concurrent with sinus augmentation
Trial population
Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who missing their upper back teeth (both sides) and interested in having implant supported dental restorations
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bone grafting on both sides
DeviceThe surgical protocol is part of standard of care and will not be changed due to the study except the choice of the bone graft. Routinely (as the standard protocol), allograft (Straumann Allograft mineralized cortical granules \[0.25-1mm\]) is mixed with xenograft (bovine bone; Bio-Oss® small particles \[0.25-1mm\]) bone graft and placed into sinus. In this study, one randomly chosen sinus will receive this mixture (50:50 by volume) as the control. The other sinus on the same patient will receive a 50:50 (by volume) mixture of the same allograft with synthetic carbonate apatite (Cytrans® granules S size \[0.3-0.6 mm\]).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Bone graft patients1 intervention
Trial outcomes
Primary outcomes
1
Change in ridge dimensions
Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner
Time frame
Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure2
Change in Bone Density
Bone density around the dental implant, measured via CBCT
Time frame
Prior to the procedure; 4 months post-procedure3
Bone quality at 6 months
At implant surgery, 6 months post-grafting, a bone core sample will be taken. This tissue is normally removed during the implant procedure but it typically discarded. Histological analysis will be done on the sample
Time frame
About 6 months post-grafting procedure4
Patient-Centered Outcomes
Participants will be asked to keep a diary to record pain level and pain medications taken.
Time frame
Days 1-10 post-procedureSponsors and contacts
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Source ClinicalTrials.gov
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