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

NCT04667260 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-18

No results posted yet for this study

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

Interventions

PROCEDURE

Maxillary sinus membrane elevation

Maxillary sinus membrane elevation with blood coagulum

PROCEDURE

Maxillary sinus floor augmentation

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

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-12-01
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667260 on ClinicalTrials.gov