Sinus Floor Augmentation and Graft Compared Sinus Membrane Elevation With Blood Coagulum. A Randomized Controlled Trial

NCT04667260 | Unknown

• 1 other identifier: N-20180080
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Implant placement in posterior maxilla is often compromised or impossible due to atrophy of the bone and pneumatisation of the maxillary sinus. Thus, alveolar ridge augmentation is frequently necessary. The most commonly used method to augment the maxillary region involves the maxillary sinus floor augmentation (MSFA) with autogenous bone graft or bone substitute. Harvesting of autogenous bone graft is associated with risk of donor site morbidity and unpredictable resorption of the graft. Thus, bone substitutes alone or in combination with autogenous bone are used increasingly. Symbios xenograft granules is a new porcine bone mineral. Long-term studies have demonstrated that xenograft contains osteoconductive properties and is a safe grafting material. MSFA with xenograft alone or in combination with autogenous bone have shown high implant survival with new bone formation. In contrast, the maxillary sinus cavities possess significant potential for bone regeneration without the use of additional bone grafts or bone substitutes due to the principle of periosteal guided bone regeneration and surrounding bony walls. Bone regeneration after maxillary sinus membrane elevation with the use of coagulum as grafting material has shown high implant survival with new bone formation, as documented in reviews and short-term studies. The objective is to test the H0-hypothesis of no difference in the long-term implant outcome after MSFA with 1:1 mixture of autogenous bone graft and Symbios xenograft (control) compared with the coagulum (test). Forty consecutively healthy patients with a missing posterior maxillary tooth will be allocated to test or control. Implants will be inserted simultaneously with the MSFA. Clinical and/or radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography (CBCT) will be performed preoperatively, immediate postoperatively, before abutment connection, after prosthetic rehabilitation, and one year after loading to assess the implant treatment outcome and the volumetric changes of the augmented area. The primary outcome will include survival of suprastructures, survival of implants, volumetric stability of the augmented area, peri-implant marginal bone level, oral health related quality of life, and complications related to the two treatment modalities.

Conditions

Dental Implant Failed

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

  After one year of functional 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

  After one year of functional loading

Secondary Outcomes (2)

• Volumetric changes of the graft material

  One year after sinus floor elevation and augmentation

• Peri-implant marginal bone level

  One year of functional loading

Study Arms (2)

Bone substitue

PLACEBO COMPARATOR

Bone augmentation with bone substitute

Procedure: Maxillary sinus membrane elevation; Procedure: Maxillary sinus floor augmentation

Coagulum

EXPERIMENTAL

Bone augmentation with coagulum

Procedure: Maxillary sinus membrane elevation; Procedure: Maxillary sinus floor augmentation

Interventions

Maxillary sinus membrane elevation PROCEDURE

Maxillary sinus membrane elevation with blood coagulum

Also known as: Sinus membrane elevation

Bone substitue; Coagulum

Maxillary sinus floor augmentation PROCEDURE

Maxillary sinus floor augmentation with 1:1 autogenous bone graft and deprotinized porcine bone mineral

Also known as: Sinus floor augmentation

Bone substitue; Coagulum

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 posterior maxillary tooth.
• Residual bone height of the maxillary alveolar process ≥4-7 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

Interventions

Sinus Floor Augmentation

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: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DDS, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 14, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2025
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)