AzTrials
AzTrials

Internal Sinus LiftingNCT07627633

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

A study testing Internal Sinus lifting using Theravex-Xenpgraft mixture and Internal Sinus lifting using Xenpgraft alone in people with Internal Sinus Lifting, run by Ain Shams University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Internal Sinus Lifting
What is being tested?
Internal Sinus lifting using Theravex-Xenpgraft mixture and Internal Sinus lifting using Xenpgraft alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
1 Oct 2026to 1 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eslam Osama Hashem, Master's contact

+201100673726

eslamhashim@dent.asu.edu.eg

Egypt1 site
  • Faculty of Dentistry Ain Shams university

    Cairo, 11566

Other trials in Egypt

About this study

Official title: 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.

Read the 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?

Being tested
Internal Sinus lifting using Theravex-Xenpgraft mixture, Internal Sinus lifting using Xenpgraft alone
Keywords
Bone Bioactive Liquid, Theravex Tissue Care, Internal Sinus Lifting, Implant, Xenograft, Sinus augmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internal Sinus lifting using Theravex-Xenpgraft mixtureBiological

    Application of a grafting mixture consisting of an equine granulate xenograft hydrated with Theravex (Bone Bioactive Liquid) into the osteotomy site.

  • Internal Sinus lifting using Xenpgraft aloneBiological

    Application of an equine granulate xenograft alone into the osteotomy site.

Study groups in NCT07627633
Study groupRoleWhat they receive
Theravex - Xenograft mixture groupExperimentalPatients 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.
Receives: Biological: Internal Sinus lifting using Theravex-Xenpgraft mixture
Xenograft alone groupActive comparatorPatients 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.
Receives: Biological: Internal Sinus lifting using Xenpgraft alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediate post-operative and 3 months post-operative

Secondary outcomes (3)
  1. 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.

    Measured: Immediate post-operative and 6 months post-operative

  2. 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.

    Measured: Immediate post operative and 6 months after surgery

  3. Oral-health-related quality of life OHIP-14

    Will be assessed using the OHIP-14 questionnaire

    Measured: Baseline (before surgery), 7 days, 3 months and 6 months post-operative.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627633
Sponsor's protocol ID
FDASU-RecIM335152
Status last verified
May 2026
First submitted
30 May 2026
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31407430
  • Tatum H Jr. Maxillary and sinus implant reconstructions. Dent Clin North Am. 1986 Apr;30(2):207-29.

    PubMed 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.

    PubMed 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.

    PubMed 36639342
  • 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.

    PubMed 39588592
  • Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.

    PubMed 8055503
  • 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

  • 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

  • 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.

    PubMed 28745002
  • 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.

    PubMed 34740571
  • 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.

    PubMed 23377064

Questions about this trial

What is this clinical trial studying?

A study testing Internal Sinus lifting using Theravex-Xenpgraft mixture and Internal Sinus lifting using Xenpgraft alone in people with Internal Sinus Lifting, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eslam Osama Hashem, Master's (+201100673726, eslamhashim@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Stability Quotient (ISQ) (time frame: Immediate post-operative and 3 months post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07627633, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in