Cross-linked hyaluronic acid biofunctionalized alloplast particulate in Sinus floor Elevation comparing two surgical approaches: a randomized clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039034

Enrollment

Registered

2026-01-20

Start date

2018-12-28

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K08.2

Interventions

Group 1: Transcrestal Sinus Floor Elevation (tSFE): Patients undergo a transcrestal sinus floor elevation using a hydrodynamic technique (Jeder® system). The sinus augmentation is performed with low-t

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Patients who wish an implant-based restoration in the posterior upper jaw - = 4mm residual bone height

Exclusion criteria

Exclusion criteria: - Questionable Compliance - Patients with systemic, general medicine diseases (coronary heart disease, rheumatoid form circle, COPD, Diabetes Mellitus type 2 with HbA1c < 6.5%) - Pregnancy/ lactation - Patients with cognitive/ physical disturbance - Patients who underwent radiotherapy affecting the head and neck area - Patients who had an intravenously perfusion of bisphosphonates - diseases affecting the sinus aeration - Patients with a previous radical operation of the maxillary sinus such as Caldwell-Luc - Tumorous alteration

Design outcomes

Primary

Measure	Time frame
Radiographically measured gain in subantral bone height (mm), sufficient for proper implant placement, assessed by CBCT approximately 5 months after sinus floor elevation.	—

Secondary

Measure	Time frame
1. Histomorphometric composition of the newly formed tissue in the augmented sinus region (percentage of new bone, connective tissue, and residual graft material), assessed from bone biopsies collected at re-entry approximately 5 months after sinus floor elevation. 2. Histological, histochemical, and immunohistochemical characterization of the newly formed tissue (including osteogenesis, vascularization, and remodeling activity) based on bone biopsies approximately 5 months postoperatively. 3. Radiographically determined bone volume using CBCT images at the time of implant placement. 4. Implant survival rate one year after functional loading of the placed implants.	—

Measure

Time frame

1. Histomorphometric composition of the newly formed tissue in the augmented sinus region (percentage of new bone, connective tissue, and residual graft material), assessed from bone biopsies collected at re-entry approximately 5 months after sinus floor elevation. 2. Histological, histochemical, and immunohistochemical characterization of the newly formed tissue (including osteogenesis, vascularization, and remodeling activity) based on bone biopsies approximately 5 months postoperatively. 3. Radiographically determined bone volume using CBCT images at the time of implant placement. 4. Implant survival rate one year after functional loading of the placed implants.

—

Countries

Germany

Contacts

Public ContactAnton Friedmann

Universität Witten/Herdecke

anton.friedmann@uni-wh.de+49 2302 926-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026