Skip to main content
OpenTrials
Completed

NCT Number: NCT07041411

Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen

Primary: Histologically analyse the quality of bone regeneration after graft material insertion in severely resorbed maxilla.

Secondary: Radiological analysis of the volume of the bone regenerations with the shirnkage rate of the graft material. clinical study of 20 patients 13 in OSSIX Bone group 13 in Bio-Oss Collagen group all patients requiring a regenerative procedure (sinus lift) having less than 3mm of residual bone height (RBH) with the impossibility to place the implants at the time of regenerative proc 6 months follow up for the first endpoint. (collection of the histological sample) 12 months follow up - long term clinical evaluation. tests performed: Cone Beam Computed Tomography (CBCT), clinical evaluation, X-ray

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sinus Lift Graft Materials Transcrestal Approach

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studi Odontoiatrici Luigi Canullo

Roma, RM, 00100, Italy

About this study

Visit 1 - Screening Visit - preoperative visit (informed consent, dental mouth cleaning, CBCT, intraoral scanning).

Visit 2 - Baseline visit - T0 (surgical procedure) Sinus elevation with OSSIX® Bone or Bio-Oss® Collagen, periapical x-ray, intraoral photo with microscope.

Visit 3 - Follow up visit - 14 days - suture removal, clinical evaluation and patient satisfaction questionnaire.

Visit 4 - Follow up visit - 180days (One week before) Cone Beam Computed Tomography (CBCT), Dental mouth cleaning, intraoral scanning.

(Second surgery) implant site preparation and histological sample collection, implant placement, insertion torque value, implant stability, peri-apical x-ray, intraoral scanning and photography.

Visit 5 - Follow up visit - 194 days suture removal and clinical evaluation. Visit 6 - Follow up visit - 270 days Implant stability, clinical examination, definitive restoration and periapical x-ray Visit 7- Follow up visit - 365 days Implant stability, peri-apical x-ray, definitive restoration, Cone Beam Computed Tomography (CBCT), intraoral scanning and picture.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient requiring vertical elevation of the maxillary sinus.
  • Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of < 3-4 mm.
  • Males and females between 30-80 years old
  • Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) <25%, Bleeding on Probing (BoP) <25%).
  • Patients that are 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 which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.

Exclusion criteria

  • Patient requiring vertical elevation of the maxillary sinus with native bone crest height > 5 mm
  • Patients who smoke over 5 cigarettes/day
  • Pregnancy (confirmed by verbal inquiry)
  • Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
  • Patients taking bisphosphonates
  • Any sites where an implant already failed sites
  • Untreated Periodontitis
  • Dental sites with acute infections
  • Chronic inflammatory diseases of the oral cavity
  • Autoimmune diseases (cortisone intake)
  • Allergy declared to one or more medicaments to be used during treatment
  • Alcoholics patients and/or drug addicts
  • Patients with known collagen hypersensitivity.
  • Patients with sensitivity to porcine-derived materials.
  • History or malignant tumors of the maxillary sinus
  • History of local radiation therapy

Treatment and study plan

maxillary sinus elevation through transcrestal approach using OSSIX® Bone

Procedure

After a careful radiologic analysis, using a surgical guide, maxillary sinus elevation through transcrestal access to sinus mucosa was achieved. The elevation of the maxillary sinus mucosa was performed through micro-elevators and graft material was inserted.

Other names: maxillary sinus elevation through transcrestal approach using Bio-Oss® Bone, Ossix Bone

Primary outcomes

  1. histological analysis

    Time frame: 6 months after graft insertion

    samples were collected and histologically and immunohistologically analyzed

Secondary outcomes

  1. radiological analyis

    Time frame: 12 months

    preoperatively Cone Beam Computed Tomography (CBCT) was compared to 12 months CBCT. The volume of bone regeneration was measured by performing a semi-automatic segmentation using a specific segmentation software (3D Slicer) and measured in mm3.

Sponsors and collaborators

Lead sponsor

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

Other

Registry information

Official study title

Histological and Radiological Evaluation of Crosslinked vs Not Cross Linked Graft in Transcretal Sinus Elevation in Severely Resorbed Maxilla. A Prospective, Controlled Study

Acronym: TSL

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.