Collagenic vs Collagen-enriched Graft in Sinus Elevation: RCT

NCT07386184 | Not Yet Recruiting

• 1 other identifier: SINUS 2
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to histologically understand if collagenic or collagen enriched graft in sinus lift of healthy volunteers needing for implants in the posterior maxillae may work. The main question it aims to answer are: which material works better histologically and radiologically? Researchers will compare a collagenic graft to collagen enriched graft to see if the osteointegration of the material is the same. Participants will undergo a sinus lift with one of the two materials and after six month will undergo a bone sample collection to allow the implant insertion. twelve moths thereafter, a radiograph will be taken to measure the extension of the bone regeneration and implant behavior

Conditions

Sinus Lift Augmentation

Keywords

Randomized controlled prospective clinical trial

Outcome Measures

Primary Outcomes (2)

• histomorphometric analysis

  For standardized analysis, each bone core will be divided into 2.5 mm-long segments. Although efforts will be made to obtain cores of uniform length (7-8 mm), there is the possibility that intact samples will be not always retrievable due to mechanical fragility during trephine extraction or decalcification. For this reason, the segmental analysis approach will be adopted as the methodological standard: poorly mineralized samples, in which only a limited segment could be evaluated, will be thus not weighted equally to longer, structurally intact specimens. Non-regenerated portions will be excluded from analysis when their mechanical integrity is compromised. Percentage of regenerated bone, native bone, graft, connective tissue will be measure

  6 months

• histologic analysis

  Hematoxylin and eosin (H\&E) staining will be used for a semi-quantitative assessment of inflammatory infiltrates, based on a previously validated scoring system.Additionally, immunohistochemistry (Osteolcin, Osteopontin, Osteonectin, RUNX2, TRAP, PAS) and Herovici, Sirius Red, RGB Trichrome will be run.

  6 months

Secondary Outcomes (2)

• linear radiologic measures

  12 months

• 3D radiologic measures

  12 months

Study Arms (2)

insertion of porcine collagenic graft in the sinus

EXPERIMENTAL

porcine graft, which, due to its deantigenation process, results to be completely enbibed with its native collagen. This was demonstrated to allow a better regeneration due to its angiogenic and osteogenic potential

Procedure: transcrestal sinus lift

bovine collagen enriched graft

ACTIVE COMPARATOR

the collagen-enriched bovine-derived bone substitute is composed predominantly of deproteinized bovine bone granules combined with a minor fraction of highly purified porcine collagen. The addition of collagen improves the handling properties and moldability of the graft, facilitating its clinical application.

Procedure: transcrestal sinus lift

Interventions

transcrestal sinus lift PROCEDURE

Transcrestal sinus floor elevation (tSFE) is a surgical technique released through the use of guided surgery and specifically designed drills aimed to release the sinus mucosa. The use of micro elevators is aimed to detach the mucosa from the bone and free the space for the graft material. Graft material is inserted using specific pluggers.

bovine collagen enriched graft; insertion of porcine collagenic graft in the sinus

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requiring vertical elevation of the maxillary sinus floor.
• Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus \<5 mm.
• Males and females between 30-80 years old
• Patients with healthy periodontal conditions (treated periodontitis, PI\<25%, BoP\<25%).
• Patients willing to sign an informed consent and participate in a clinical study.
• Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
• Teeth at the surgical site requiring extraction were removed at least 12 weeks prior to sinus floor elevation.

You may not qualify if:

• Patients who smoke more than 5 cigarettes/day
• Pregnancy (confirmed by verbal inquiry)
• Chronic systemic pathologies (e.g. diabetes) and neoplasms of the oro-facial district.
• Patients undergoing treatment with antiresorptive agents.
• Patients receiving systemic corticosteroid therapy.
• Any site with a history of implant failure.
• Dental sites with acute infections.
• Chronic inflammatory diseases of the oral cavity.
• Autoimmune diseases.
• Documented hypersensitivity to any of the medications intended for use during the treatment protocol.
• Substance abusers.
• Patients with known collagen hypersensitivity.
• Patients with hypersensitivity to porcine-derived materials.
• History of malignant tumors of the maxillary sinus.
• History of head/neck radiation therapy.

Sponsors & Collaborators

• Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo: lead

Central Study Contacts

luigi Canullo, Prof

CONTACT

+39 347 6201976; luigicanullo@yahoo.com

Study Design

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

Model Details: All patients will undergo the same intervention (sinus lift with crystal approach) using two different graft materials

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share