The purpose of this clinical study is to evaluate the clinical and radiographic efficacy of Theravex Tissue Care Plus (Bone Bioactive Liquid) as an adjunct to a xenograft in crestal maxillary sinus elevation with simultaneous implant placement using the osseodensification technique. The study will enroll 16 partially edentulous patients who have inadequate posterior maxillary bone height. Participants will randomly undergo the sinus elevation and implant placement utilizing either a xenograft alone or a mixture of the xenograft and Theravex. The main question the study aims to answer is whether the adjunctive use of Theravex with a xenograft enhances vertical bone gain, bone density, and implant stability compared to using a xenograft alone.
Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
Both genders will be selected males and females.
Adult patients aged between 21 and 50 years of age.
Good general health (American Society of Anesthesiology Physical Status I-II).
Smokers
Pregnant and lactating females.
Poor oral hygiene (Full-Mouth Plaque Score (FMPS) > 20%).
Patients with occlusal or malalignment problems.
Parallel
Internal Sinus lifting using Theravex-Xenpgraft mixture
Biological/VaccineApplication of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site.
Internal Sinus lifting using Xenpgraft alone
Biological/VaccineApplication of an equine granulate xenograft alone into the osteotomy site.
Implant Stability Quotient (ISQ)
ISQ will be recorded at baseline immediately post-operative. Repeating ISQ measurements will be taken for 3 months post-operatively to evaluate the transition from primary to secondary stability
Bone Density
Bone density will be assessed at 6 months using cone-beam computed tomography (CBCT). Bone density at the apical region of the implant (the area of vertical bone gain) will be measured immediately and 6 months post-operatively using OnDemand 3D software. Values will be recorded in Hounsfield Units (HU), comparing pre-operative (via virtual implant) and post-operative scans. To determine the mean peri-implant bone density, measurements from four standardized reference points (mesial, distal, buccal, and palatal) will be averaged.
Vertical Bone Gain
VBG will be assessed at baseline (immediate post operative and 6 months after surgery) Specialized 3D imaging software will be utilized to superimpose the pre-operative and immediate post-operative cone-beam computed tomography (CBCT) scans. This digital superimposition will facilitate a precise comparison of dimensional changes at the specific implant sites, enabling accurate measurement and quantification of the vertical bone height achieved following the sinus elevation.
Oral-health-related quality of life OHIP-14
Will be assessed using the OHIP-14 questionnaire
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