Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The posterior maxilla presents a significant clinical challenge for implant placement due to progressive alveolar resorption, sinus pneumatization, and suboptimal bone density. Addressing these deficiencies typically necessitates sinus floor augmentation to restore the vertical bone height required for achieving adequate primary stability.
Crestal sinus floor elevation via osseodensification addresses these deficiencies by preserving and compacting alveolar bone, which increases primary stability and facilitates hydrodynamic membrane elevation. To maintain the newly created vertical space, this technique is frequently combined with bone substitutes like demineralized bone matrix (DBM) xenografts. However, optimizing the biological graft-tissue interface to accelerate healing remains a critical goal.
Bone Bioactive Liquid (BBL, Theravex Tissue Care Plus) is a novel, negatively charged phosphate saline solution containing calcium and magnesium chlorides that fundamentally alters the implant-tissue interface. While Theravex is proven to enhance implant wettability, modulate inflammatory responses, and accelerate osseointegration, its potential as a biologic adjunct to hydrate the graft matrix during osseodensification-mediated sinus augmentation currently remains unexplored.
This randomized, controlled, parallel design, two-arm clinical trial (RCT) will enroll 16 partially edentulous patients. Eligible patients will have an initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT. The study will be a double-blinded clinical study, meaning blinding includes the patient and the assessor. After confirmation of eligibility and completion of baseline records, patients will be randomized 1:1 using computer-generated blocks
Participants will be allocated into the following two treatment arms:
Group I (Test Group): Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing a mixture of Theravex (Bone Bioactive Liquid) and xenograft and as the grafting material.
Group II (Control Group): Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing xenograft alone as the grafting material.
Aim of the Study:
This study will be performed to evaluate the clinical and radiographic efficacy of Theravex Tissue Care Plus (Bone Bioactive Liquid) as an adjunct to xenograft grafting in crestal maxillary sinus elevation with simultaneously implant placement using osseodensification technique.
Research Question:
In patients undergoing crestal maxillary sinus elevation via osseodensification, does adjunctive use of Theravex (bone bioactive liquid) with a xenograft enhance vertical bone gain, bone density, and implant stability compared to xenograft alone?
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theravex - Xenograft mixture group | Experimental | Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing a mixture of Theravex (Bone Bioactive Liquid) and xenograft and as the grafting material. |
|
| Xenograft alone group | Active Comparator | Patients in this group will undergo internal maxillary sinus lift via the osseodensification technique with simultaneous dental implant placement, utilizing xenograft alone as the grafting material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal Sinus lifting using Theravex-Xenpgraft mixture | Biological | Application of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate post-operative and 3 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eslam Osama Hashem, Master's | Contact | +201100673726 | eslamhashim@dent.asu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Ain Shams university | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17224026 | Background | Zizelmann C, Schoen R, Metzger MC, Schmelzeisen R, Schramm A, Dott B, Bormann KH, Gellrich NC. Bone formation after sinus augmentation with engineered bone. Clin Oral Implants Res. 2007 Feb;18(1):69-73. doi: 10.1111/j.1600-0501.2006.01295.x. | |
| 31662363 | Background | Yan Q, Wu X, Su M, Hua F, Shi B. Short implants (</=6 mm) versus longer implants with sinus floor elevation in atrophic posterior maxilla: a systematic review and meta-analysis. BMJ Open. 2019 Oct 28;9(10):e029826. doi: 10.1136/bmjopen-2019-029826. |
| Label | URL |
|---|---|
| Bergamo, E. T. P., Zahoui, A., Barrera, R. B., Huwais, S., Coelho, P. G., Karateew, E. D., \& Bonfante, E. A. (2021). Osseodensification effect on implants primary and secondary stability: Multicenter controlled clinical trial. Clinical Implant Dentistry | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Internal Sinus lifting using Xenpgraft alone | Biological | Application of an equine granulate xenograft alone into the osteotomy site. |
|
| Immediate post-operative and 6 months post-operative |
| 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. | Immediate post operative and 6 months after surgery |
| Oral-health-related quality of life OHIP-14 | Will be assessed using the OHIP-14 questionnaire | Baseline (before surgery), 7 days, 3 months and 6 months post-operative. |
| 21986455 | Background | Won YH, Kim SG, Oh JS, Lim SC. Clinical evaluation of demineralized bone allograft for sinus lifts in humans: a clinical and histologic study. Implant Dent. 2011 Dec;20(6):460-4. doi: 10.1097/ID.0b013e31823541e7. |
| 14971260 | Background | Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328. |
| 31407430 | Background | Testori T, Weinstein T, Taschieri S, Wallace SS. Risk factors in lateral window sinus elevation surgery. Periodontol 2000. 2019 Oct;81(1):91-123. doi: 10.1111/prd.12286. |
| 3516738 | Background | Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. |
| 40693126 | Background | Starch-Jensen T, Ostergaard KB, Bruun NH, Shino IL, Hallund MH. Transcrestal Maxillary Sinus Membrane Elevation using Osseodensification Compared with Alveolar Ridge Augmentation using the Lateral Window or Osteotome Technique: a Systematic Review and Meta-Analysis. J Oral Maxillofac Res. 2025 Jun 30;16(2):e1. doi: 10.5037/jomr.2025.16201. eCollection 2025 Apr-Jun. |
| 36639342 | Background | Starch-Jensen T, Bruun NH, Spin-Neto R. Outcomes following osteotome-mediated sinus floor elevation with Bio-Oss Collagen or no grafting material: a one-year single-blind randomized controlled trial. Int J Oral Maxillofac Surg. 2023 Sep;52(9):988-997. doi: 10.1016/j.ijom.2022.12.009. Epub 2023 Jan 12. |
| 39588592 | Background | Song P, He D, Ren S, Fan L, Sun J. Platelet-rich fibrin in dentistry. J Appl Biomater Funct Mater. 2024 Jan-Dec;22:22808000241299588. doi: 10.1177/22808000241299588. |
| 8055503 | Background | Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162. |
| Background | Neiva, R., Tanello, B., Duarte, W., & Silva, F. (2018). Osseodensification crestal sinus floor elevation with or without synthetic and resorbable calcium phosphosilicate putty. Clinical Oral Implants Research, 29(S17), 446-446 |
| Background | Mansour, A., Al-Hamed, F. S., Torres, J., & Marino, F. T. (2020). Alveolar bone grafting: Rationale and clinical applications. Dental Implants and Bone Grafts: Materials and Biological Issues, 43-87 |
| 28745002 | Background | Levi I, Halperin-Sternfeld M, Horwitz J, Zigdon-Giladi H, Machtei EE. Dimensional changes of the maxillary sinus following tooth extraction in the posterior maxilla with and without socket preservation. Clin Implant Dent Relat Res. 2017 Oct;19(5):952-958. doi: 10.1111/cid.12521. Epub 2017 Jul 26. |
| 34740571 | Background | Kuo PY, Lin CY, Chang CC, Wang YM, Pan WL. Grafted bone remodeling following transcrestal sinus floor elevation: A cone-beam computed tomography study. Biomed J. 2021 Oct;44(5):627-635. doi: 10.1016/j.bj.2020.05.011. Epub 2020 May 26. |
| 23377064 | Background | Kim YK, Hwang JY, Yun PY. Relationship between prognosis of dental implants and maxillary sinusitis associated with the sinus elevation procedure. Int J Oral Maxillofac Implants. 2013 Jan-Feb;28(1):178-83. doi: 10.11607/jomi.2739. |
| 30427961 | Background | Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770. |
| Background | Hashem, A. H., Khedr, M. F., Hosny, M. M., El-Destawy, M. T., & Hashem, M. I. (2023). Effect of Different Crestal Sinus Lift Techniques for Implant Placement in the Posterior Maxilla of Deficient Height: A Randomized Clinical Trial. Applied Sciences 2023, Vol. 13, Page 6668, 13(11), 6668 |
| 41110400 | Background | Gong T, Wang LQ, Tong X, Zhang Y, Shu LJ. Impact of Age-Related Bone Density Variations on Dental Implant Stability and Success Rates: A Retrospective Analysis. Int Dent J. 2025 Dec;75(6):103942. doi: 10.1016/j.identj.2025.103942. Epub 2025 Oct 18. |
| Background | Garoushi, I., mehdawi, manaaer, Aldarnawi, F., Elmake, F., BenAli, N., & Othman, elsanousi. (2025). Awareness toward dental implants as a treatment option for replacement of missing teeth : A Cross-sectional study. Ain Shams Dental Journal, 37, 141-147 |
| 36294864 | Background | Ferres-Amat E, Al Madhoun A, Ferres-Amat E, Carrio N, Barajas M, Al-Madhoun AS, Ferres-Padro E, Marti C, Atari M. Comparison of 0.12% Chlorhexidine and a New Bone Bioactive Liquid, BBL, in Mouthwash for Oral Wound Healing: A Randomized, Double Blind Clinical Human Trial. J Pers Med. 2022 Oct 16;12(10):1725. doi: 10.3390/jpm12101725. |
| 35840446 | Background | Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13. |
| 22082056 | Background | Del Fabbro M, Corbella S, Weinstein T, Ceresoli V, Taschieri S. Implant survival rates after osteotome-mediated maxillary sinus augmentation: a systematic review. Clin Implant Dent Relat Res. 2012 May;14 Suppl 1:e159-68. doi: 10.1111/j.1708-8208.2011.00399.x. Epub 2011 Nov 14. |
| 27540841 | Background | Carreno Carreno J, Aguilar-Salvatierra A, Gomez-Moreno G, Garcia Carreno EM, Menendez Lopez-Mateos ML, Perrotti V, Piattelli A, Calvo-Guirado JL, Menendez-Nunez M. Update of Surgical Techniques for Maxillary Sinus Augmentation: A Systematic Literature Review. Implant Dent. 2016 Dec;25(6):839-844. doi: 10.1097/ID.0000000000000467. |
| 17716261 | Background | Browaeys H, Bouvry P, De Bruyn H. A literature review on biomaterials in sinus augmentation procedures. Clin Implant Dent Relat Res. 2007 Sep;9(3):166-77. doi: 10.1111/j.1708-8208.2007.00050.x. |
| 6993637 | Background | Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available. |
| 34047046 | Background | Bergamo ETP, Zahoui A, Barrera RB, Huwais S, Coelho PG, Karateew ED, Bonfante EA. Osseodensification effect on implants primary and secondary stability: Multicenter controlled clinical trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):317-328. doi: 10.1111/cid.13007. Epub 2021 May 27. |
| 39452591 | Background | Al Madhoun A, Meshal K, Carrio N, Ferres-Amat E, Ferres-Amat E, Barajas M, Jimenez-Escobar AL, Al-Madhoun AS, Saber A, Abou Alsamen Y, Marti C, Atari M. Randomized Clinical Trial: Bone Bioactive Liquid Improves Implant Stability and Osseointegration. J Funct Biomater. 2024 Oct 1;15(10):293. doi: 10.3390/jfb15100293. |