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

May 30, 2026 updated by: Eslam Hashem, Ain Shams University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Faculty of dentistry Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Biological: Internal Sinus lifting using Xenpgraft alone
Application of an equine granulate xenograft alone into the osteotomy site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability Quotient (ISQ)
Time Frame: Immediate post-operative and 3 months post-operative
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Density
Time Frame: Immediate post-operative and 6 months post-operative

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
Vertical Bone Gain
Time Frame: Immediate post operative and 6 months after surgery
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
Time Frame: Baseline (before surgery), 7 days, 3 months and 6 months post-operative.
Will be assessed using the OHIP-14 questionnaire
Baseline (before surgery), 7 days, 3 months and 6 months post-operative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-RecIM335152

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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