RCT With 3 Different Biomaterials for Maxillary Sinus Lift

NCT04506827 | Completed Phase 4

• 1 other identifier: SinusAug
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and quality of bone suitable for receiving osseointegrated implants, its success is largely due to the skill of the surgeon, but also to the characteristics of the biomaterial used. Methods: Twenty-four patients needing MSA were included in the study. The patients were randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control, Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes were mean bone gain, intraoperative and post-operative complications, implant insertion torque, implant failure and patient related outcome measures (PROMs).

Conditions

Alveolar Bone Atrophy

Keywords

Bone regeneration; Biomaterial(s); Implantology; Osseointegration

Outcome Measures

Primary Outcomes (2)

• Histomorphometric parameters of the augmented bone (descriptive)

  Descriptive analysis of the specimen section at the microscope

  9 months

• Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)

  Percentages of newly formed bone, marrow spaces and residual graft particles are reported.

  9 months

Secondary Outcomes (7)

• Mean bone gain measured at 9 months through CBCT evaluation

  9 months

• Intra-operative

  During surgery

• Post-operative complications

  one week

• Post-operative complications

  9 months

• Implant insertion torque measured in Ncm

  9 months

Study Arms (3)

Control group

ACTIVE COMPARATOR

patients in the control group received Demineralized Bovine Bone Mineral for the maxillary sinus augmentation

Procedure: Maxillary Sinus Augmentation; Device: Maxillary Sinus Graft with ABBM

Test group 1

EXPERIMENTAL

patients in the test group 1 received TCP with particle size from 250 to 1000 µm

Procedure: Maxillary Sinus Augmentation; Device: Maxillary Sinus Graft with TCP

Test group 2

EXPERIMENTAL

patients in the test group 2 received TCP as in test group1 plus crosslinked Hyaluronic Acid

Procedure: Maxillary Sinus Augmentation; Device: Maxillary Sinus Graft with TCP + HA

Interventions

Maxillary Sinus Augmentation PROCEDURE

Biomaterial Graft into the Maxillary Sinus

Control group; Test group 1; Test group 2

Maxillary Sinus Graft with ABBM DEVICE

The maxillary sinuses in the control group are grafted with ABBM

Also known as: Anorganic Bovine Bone Mineral (ABBM)

Control group

Maxillary Sinus Graft with TCP DEVICE

The maxillary sinuses in the test1 group are grafted with TCP

Also known as: Tricalcium Phosphate (TCP)

Test group 1

Maxillary Sinus Graft with TCP + HA DEVICE

The maxillary sinuses in the test1 group are grafted with TCP + HA

Also known as: hyaluronic acid (HA)

Test group 2

Eligibility Criteria

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

You may qualify if:

• need for maxillary sinus augmentation
• years or older
• residual ridge height less than 3mm

You may not qualify if:

• full contraindication to implant surgery,
• systemic diseases that could negatively influence wound healing;
• heavy smokers (more than 10 cigarettes/day);
• head and neck irradiation treatment;
• uncontrolled diabetes;
• chronic or acute sinus pathology;
• uncontrolled periodontal disease;
• full mouth plaque and bleeding score higher than 25%,
• tooth extractions in the previous 2 months

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Geneva

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Officials

• Nicola A Valente, DDS, MS

  University of Seville, Spain

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The envelope with the group assignment will be opened by the surgeon at the time of surgery and the patient won't be informed. The clinician who registers clinical parameters won't be informed of the group allocation. The histologist will receive biopsies with a numeric code but without informations of the graft material used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three groups of patients will be treated with 3 different graft materials

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 10, 2020
• Study Start: February 23, 2017
• Primary Completion: June 29, 2019
• Study Completion: December 14, 2019
• Last Updated: August 10, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)