Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus

NCT03496688 | Completed DMC

• 1 other identifier: 3447/18.12.2014
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.

Conditions

Atrophy; Jaw, Edentulous, Partially; Sinus Floor Augmentation; Bone Substitutes; Bone Regeneration

Keywords

Sinus floor augmentation; Bone regeneration; Histology; Biocompatible materials; Bone transplantation

Outcome Measures

Primary Outcomes (1)

• to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.

  After 6 months clinical and radiographic examinations were undertaken and each patient was reappointed for biopsy at the time of implant placement in the same location. Under local anesthesia, a full thickness flap was raised, a biopsy was performed using a 3.5 mm tre-phine bur under sterile saline solution irrigation, guided by the radiographic/surgical template in the selected implant site. A total of six bone samples was retrieved from the occlusal aspect to the alveolar crest, one from each augmented site to compare histologically and histomorphometrically the different materials.

  6 month-healing after surgery

Study Arms (6)

bone substitute material MCBA

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using mineralized sol-vent-dehydrated bone allograft material.

Procedure: Sinus floor augmentation

bone substitute material FDBA

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using freeze-dried mineralized bone allograft material.

Procedure: Sinus floor augmentation

bone substitute material ABB

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using anorganic bovine bone material.

Procedure: Sinus floor augmentation

bone substitute material EB

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using equine-derived bone material.

Procedure: Sinus floor augmentation

bone substitute material HA-β-TCP 30/70

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using synthetic micromacroporous bi-phasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hy-droxyapatite material.

Procedure: Sinus floor augmentation

bone substitute material BC

ACTIVE COMPARATOR

Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using bioapatite-collagen material.

Procedure: Sinus floor augmentation

Interventions

Sinus floor augmentation PROCEDURE

bone substitute material ABB; bone substitute material BC; bone substitute material EB; bone substitute material FDBA; bone substitute material HA-β-TCP 30/70; bone substitute material MCBA

Eligibility Criteria

• Age: 33 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (1)

• La Monaca G, Iezzi G, Cristalli MP, Pranno N, Sfasciotti GL, Vozza I. Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-Stage Maxillary Sinus Augmentation Model after 6-Month Healing. Biomed Res Int. 2018 Jun 27;2018:9430989. doi: 10.1155/2018/9430989. eCollection 2018.

  PMID: 30050947 DERIVED

MeSH Terms

Conditions

Atrophy; Jaw, Edentulous, Partially

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maria Paola Cristalli, DDS

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, Investigator, Outcome Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS PhD, Clinical Professor

Model Details: A randomized,controlled, double-blind clinical trial

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 12, 2018
• Study Start: January 12, 2015
• Primary Completion: January 4, 2016
• Study Completion: September 11, 2017
• Last Updated: April 12, 2018

Record last verified: 2018-04