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Maxillary Sinus Floor Augmentation With Different Grafting Materials

NCT04749953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-11

No results posted yet for this study

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

Interventions

PROCEDURE

Maxillary sinus floor augmentation

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

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
2021-01-01
Completion
2021-01-20

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 NCT04749953 on ClinicalTrials.gov