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

30 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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?

Studietyp

Interventionell

Inskrivning (Beräknad)

16

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studieorter

  • Egypten
      • Cairo, Egypten, 11566
        • Faculty Of Dentistry Ain Shams University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Biologisk: 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.
Aktiv komparator: 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.
Biologisk: Internal Sinus lifting using Xenpgraft alone
Application of an equine granulate xenograft alone into the osteotomy site.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Implant Stability Quotient (ISQ)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Bone Density
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Ain Shams University

Publikationer och användbara länkar

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Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 oktober 2028

Avslutad studie (Beräknad)

1 maj 2029

Studieregistreringsdatum

Först inskickad

30 maj 2026

Först inskickad som uppfyllde QC-kriterierna

30 maj 2026

Första postat (Faktisk)

4 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • FDASU-RecIM335152

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