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Maxillary Sinus Floor Augmentation in Diabetic Patients

NCT04543630 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-13

No results posted yet for this study

Summary

Placement of implants in diabetic patients is associated with higher risk of implant failure and peri-implant marginal bone loss due to an increased susceptibility to infections, impaired wound healing and associated microvascular complications. However, diabetic patients do not encounter a higher implant failure rate compared with non-diabetic patients, if the plasma glucose levels are normal.

Prosthetic rehabilitation of the posterior maxilla with implants is frequently compromised due to atrophy of the alveolar process and pneumatisation of the maxillary sinus. Maxillary sinus floor augmentation (MSFA) with autogenous bone graft is generally considered the preferred grafting material due to its osteoinductive, osteogenic, and osteoconductive properties. However, harvesting of autogenous bone graft is associated with risk of donor site morbidity and unpredictable resorption of the graft. Thus, bone substitutes, blood coagulum and platelet rich fibrin are used increasingly to simplify the surgical procedure.

Fabrication of advanced platelet rich fibrin (APRF) from blood samples possess significant potential for bone regeneration without the use of additional autogenous bone grafts or bone substitutes. Consequently, use of APRF in conjunction with MSFA will avoid bone harvesting and simplify the surgical procedure.

The objective is to test the H0-hypothesis of no difference in implant treatment outcome after MSFA with particulated autogenous bone graft compared with APRF. Forty consecutively insulin-dependent diabetes patients with missing posterior maxillary tooth/teeth will be allocated to implant placement and MSFA with particulated autogenous bone graft from the zygomatic buttress or APRF. Blood samples will be obtained preoperatively and postoperatively. Clinical and radiographical evaluation using periapical radiographs and CBCT will be performed preoperatively, immediate postoperatively, before abutment connection, after prosthetic rehabilitation, one year, three years and five years after loading to assess the implant treatment outcome and the volumetric changes of the augmented area. Outcome measures will include survival of suprastructures and implants, volumetric stability of the augmented area, peri-implant marginal bone level, immunological analyses of blood samples, oral health related quality of life, and complications related to the two treatment modalities.

Conditions

Interventions

PROCEDURE

Sinus floor augmentation

Sinus floor augmentaion using the lateral window technique

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-06-01
Completion
2028-12-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT04543630 on ClinicalTrials.gov