Transcrestal Sinus Lift With OSSIX Bone vs BIOSS Collagen

NCT ID: NCT07041411

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2025-03-22

Brief Summary

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

Detailed Description

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.

Conditions

Sinus Lift; Graft Materials; Transcrestal Approach

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

OSSIX Bone

OSSIX® Bone in the maxillary sinus elevation.

Group Type: EXPERIMENTAL

maxillary sinus elevation through transcrestal approach using OSSIX® Bone

Intervention Type: 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.

Bio-Oss collagen

Bio-Oss Collagen in the maxillary sinus elevation.

Group Type: ACTIVE_COMPARATOR

maxillary sinus elevation through transcrestal approach using OSSIX® Bone

Intervention Type: 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.

Interventions

maxillary sinus elevation through transcrestal approach using OSSIX® Bone

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.

Intervention Type: PROCEDURE

Other Intervention Names

maxillary sinus elevation through transcrestal approach using Bio-Oss® Bone; Ossix Bone

Eligibility Criteria

Inclusion Criteria

1. Patient requiring vertical elevation of the maxillary sinus.

2. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of < 3-4 mm.

3. Males and females between 30-80 years old

4. Patients with healthy periodontal conditions (Treated periodontitis, Plaque Index (PI) <25%, Bleeding on Probing (BoP) <25%).

5. Patients that are willing to sign an informed consent and participate in a clinical Study.

6. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.

7. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.

Exclusion Criteria

1. Patient requiring vertical elevation of the maxillary sinus with native bone crest height > 5 mm

2. Patients who smoke over 5 cigarettes/day

3. Pregnancy (confirmed by verbal inquiry)

4. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.

5. Patients taking bisphosphonates

6. Any sites where an implant already failed sites

7. Untreated Periodontitis

8. Dental sites with acute infections

9. Chronic inflammatory diseases of the oral cavity

10. Autoimmune diseases (cortisone intake)

11. Allergy declared to one or more medicaments to be used during treatment

12. Alcoholics patients and/or drug addicts

13. Patients with known collagen hypersensitivity.

14. Patients with sensitivity to porcine-derived materials.

15. History or malignant tumors of the maxillary sinus

16. History of local radiation therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Luigi Canullo

prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Studi Odontoiatrici Luigi Canullo

Roma, RM, Italy

Countries

Italy

Other Identifiers

dontiart

Identifier Type: -

Identifier Source: org_study_id