Maxillary Sinus Floor Augmentation With Different Grafting Materials

NCT04749953 | Completed

• 1 other identifier: Thomas Starch-Jensen1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Implant placement in the posterior maxilla is compromised due to atrophy of the alveolar process and maxillary sinus pneumatisation. Bone augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the posterior maxillary involves maxillary sinus floor augmentation (MSFA) with autogenous bone graft or bone substitute. Autogenous bone graft harvesting is associated with risk of donor site morbidity and unpredictable resorption of graft. Thus, bone substitutes alone or in combination with autogenous bone are used increasingly to simplify the surgical procedure. Symbios biphasic biomaterial is a resorbable inorganic bone forming material derived from red algae consisting of 20% hydroxylapatite and 80% β-tricalciumphosphate with osteoconductive properties. Histologic and radiographic examinations indicate that β-tricalciumphosphate is slowly resorbed and replaced with bone. MSFA with β-tricalciumphosphate alone or in combination with autogenous bone or other bone substitutes have demonstrated high implant survival and new bone. Symbios xenograft granules is a porcine bone mineral with osteoconductive properties. Histologic and radiographic examinations indicate that xenograft is a non-resorbable graft material. MSFA with xenograft alone or in combination with autogenous bone have shown high implant survival and new bone. The objective is to test the H0-hypothesis of no difference in implant outcome after MSFA with autogenous bone graft or in combination with Symbios biphasic biomaterial or Symbios xenograft. 60 consecutively healthy patients with a missing posterior maxillary tooth/teeth will be randomly allocated to: 1) MSFA with autogenous bone graft, 2) MSFA with mixture of 50% autogenous bone graft and 50% Symbios biphasic biomaterial 3) MSFA with mixture of 50% autogenous bone graft and 50% Symbios xenograft. Implants will be inserted simultaneously with MSFA. Clinical and/or radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography will be performed preoperatively, immediate postoperatively, before abutment connection, after prosthetic rehabilitation, and after one year to assess the treatment outcome and volumetric changes of the augmented area. Outcome include survival of suprastructures and implants, volumetric stability of graft, peri-implant marginal bone level, oral health related quality of life, and complications.

Conditions

Survival, Prosthesis; Peri-Implantitis; Patient Satisfaction

Keywords

Alveolar ridge augmentation; Maxillary sinus floor elevation; Patient-reported outcome measures; Dental implants; Biomaterials

Outcome Measures

Primary Outcomes (2)

• Survival of suprastructures

  Loss of suprastructures is defined as a total loss because of a non-treatable mechanical/or biological complication

  One year of implant loading

• Survival of implants

  Loss of implants is defined as removal of a non-integrated implant, mobility of previously clinical osseointegrated implant, and removal of non-mobile implants due to progressive peri-implant marginal bone loss and infection

  One year of implant loading

Secondary Outcomes (4)

• Volumetric changes of the graft material

  One year of implant loading

• Peri-implant marginal bone level

  One year of functional loading

• Patient-reported outcome measures

  One year of functional implant loading

• Complications

  One year of functional implant loading

Study Arms (3)

Autogenous bone graft alone

ACTIVE COMPARATOR

Maxillary sinus floor augmentation with particulated autogenous bone graft alone from the zygomatic buttress area and simultaneously implant placement

Procedure: Maxillary sinus floor augmentation

Mixture of 50% autogenous bone graft and 50% Symbios biphasic biomaterial

EXPERIMENTAL

Maxillary sinus floor augmentation with a mixture of 50% particulated autogenous bone graft from the zygomatic buttress area and 50% Symbios biphasic bone graft material (Biomaterial, 1.0 mm to 2.0 mm) with simultaneously implant placementand

Procedure: Maxillary sinus floor augmentation

Mixture of 50% autogenous bone graft and 50% Symbios xenograft granules

EXPERIMENTAL

Maxillary sinus floor augmentation with a mixture of 50% particulated autogenous bone graft from the zygomatic buttress area and 50% Symbios xenograft granules (Biomaterial, 1.0 mm to 2.0 mm) with simultaneously implant placement

Procedure: Maxillary sinus floor augmentation

Interventions

Maxillary sinus floor augmentation PROCEDURE

The sinus membrane of the maxillary sinus is elevated to create a space for the grafting material and placement of dental implants in the posterior maxilla

Autogenous bone graft alone; Mixture of 50% autogenous bone graft and 50% Symbios biphasic biomaterial; Mixture of 50% autogenous bone graft and 50% Symbios xenograft granules

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>20 years
• Missing one or more posterior maxillary teeth
• Residual bone height of the maxillary alveolar process between 3 to 7 mm
• Width of the alveolar process ≥6.5 mm.
• Mandibular occluding teeth

You may not qualify if:

• Contraindications to implant therapy
• Full mouth plaque score \>25%
• Progressive marginal periodontitis
• Acute infection in the area intended for implant placement
• Parafunction, bruxism, or clenching
• Psychiatric problems or unrealistic expectations
• Heavy tobacco use, define as \>10 cigarettes per day
• Pregnancy

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

MeSH Terms

Conditions

Prosthesis Failure; Peri-Implantitis; Patient Satisfaction

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded to the used grafting material.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, chief surgeon, DDS, PhD

Model Details: A single-blinded randomized controlled study. No drug or device is tested. Different grafting materials for bone augmentation is compared. Autogenous bone graft is golden standard, which is compared with two different mixtures of alternative grafting materials.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 11, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 20, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)