Efficacy of Adjunctive Theravex Tissue Care® With Xenograft in Internal Sinus Lifting

Official title

Efficacy of Adjunctive Theravex Tissue Care® With Xenograft Using Osseodensification in Internal Sinus Lifting: a Randomized Controlled Clinical Study

Overview

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.

Detailed description

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?

Interventions

• Biological Internal Sinus lifting using Theravex-Xenpgraft mixture
  Application of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site.
• Biological Internal Sinus lifting using Xenpgraft alone
  Application of an equine granulate xenograft alone into the osteotomy site.

Primary outcome measures

• Implant Stability Quotient (ISQ) [Time frame: Immediate post-operative and 3 months post-operative]

Secondary outcome measures (3)

• Bone Density [Time frame: Immediate post-operative and 6 months post-operative]
• Vertical Bone Gain [Time frame: Immediate post operative and 6 months after surgery]
• Oral-health-related quality of life OHIP-14 [Time frame: Baseline (before surgery), 7 days, 3 months and 6 months post-operative.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry Ain Shams university — Cairo

Publications

• 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. PMID 17224026
• 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. PMID 31662363
• 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. PMID 21986455
• 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. PMID 14971260
• 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. PMID 31407430
• Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29. PMID 3516738
• 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. PMID 40693126
• 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. PMID 36639342

Identifiers

NCT: NCT07627633 · FDASU-RecIM335152

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗