Efficacy of Adjunctive Theravex Tissue Care® With Xenograft in Internal Sinus Lifting
Efficacy of Adjunctive Theravex Tissue Care® With Xenograft Using Osseodensification in Internal Sinus Lifting: a Randomized Controlled Clinical Study
研究概览
地位
条件
详细说明
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?
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Eslam Osama Hashem, Master's
- 电话号码：+201100673726
- 邮箱：eslamhashim@dent.asu.edu.eg
学习地点
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Cairo、埃及、11566
- Faculty Of Dentistry Ain Shams University
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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).
- Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
- No previous surgery or radiation treatment on the maxillary sinus
Exclusion Criteria:
- Smokers
- Pregnant and lactating females.
- Poor oral hygiene (Full-Mouth Plaque Score (FMPS) > 20%).
- Patients with occlusal or malalignment problems.
- Patients with parafunctional habits.
- Presence of acute or chronic sinus pathoses or sinus membrane perforation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Theravex - Xenograft mixture 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.
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Application of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site.
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有源比较器：Xenograft alone 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.
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Application of an equine granulate xenograft alone into the osteotomy site.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Implant Stability Quotient (ISQ)
大体时间：Immediate post-operative and 3 months post-operative
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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
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Immediate post-operative and 3 months post-operative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Bone Density
大体时间：Immediate post-operative and 6 months post-operative
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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. |
Immediate post-operative and 6 months post-operative
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Vertical Bone Gain
大体时间：Immediate post operative and 6 months after surgery
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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.
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Immediate post operative and 6 months after surgery
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Oral-health-related quality of life OHIP-14
大体时间：Baseline (before surgery), 7 days, 3 months and 6 months post-operative.
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Will be assessed using the OHIP-14 questionnaire
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Baseline (before surgery), 7 days, 3 months and 6 months post-operative.
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合作者和调查者
出版物和有用的链接
一般刊物
- Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.
- 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.
- Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- 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.
- 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.
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- 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.
- 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.
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- 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
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- 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.
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- 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.
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研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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