Efficacy of Adjunctive Theravex Tissue Care® With Xenograft in Internal Sinus Lifting
Summary
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.
Timeline
- Start
- 2026-10-01
- Primary completion
- 2028-10-01
- Completion
- 2029-05-01
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Background Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Theravex | Unknown | — | — |
| Comparator | Xenograft | Other / unclassified | — | — |
Indications
No indication recorded.