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

NCT07627633 | Not Yet Recruiting

• 1 other identifier: FDASU-RecIM335152
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Internal Sinus Lifting

Keywords

Bone Bioactive Liquid; Theravex Tissue Care; Internal Sinus Lifting; Implant; Xenograft; Sinus augmentation

Outcome Measures

Primary Outcomes (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

  Immediate post-operative and 3 months post-operative

Secondary Outcomes (3)

• Bone Density

  Immediate post-operative and 6 months post-operative

• Vertical Bone Gain

  Immediate post operative and 6 months after surgery

• Oral-health-related quality of life OHIP-14

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

Study Arms (2)

Theravex - Xenograft mixture group

EXPERIMENTAL

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

Xenograft alone group

ACTIVE COMPARATOR

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

Interventions

Internal Sinus lifting using Theravex-Xenpgraft mixture BIOLOGICAL

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

Theravex - Xenograft mixture group

Internal Sinus lifting using Xenpgraft alone BIOLOGICAL

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

Xenograft alone group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams university

Cairo, 11566, Egypt

Location

Related Publications (27)

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Related Links

• Bergamo, E. T. P., Zahoui, A., Barrera, R. B., Huwais, S., Coelho, P. G., Karateew, E. D., \& Bonfante, E. A. (2021). Osseodensification effect on implants primary and secondary stability: Multicenter controlled clinical trial. Clinical Implant Dentistry

Central Study Contacts

Eslam Osama Hashem, Master's

CONTACT

+201100673726; eslamhashim@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

EG (1)