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Osteotome-mediated Sinus Floor Elevation With or Without Grafting Material

NCT04618900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-06

No results posted yet for this study

Summary

Implant placement in the posterior part of the maxilla is frequently compromised or impossible due to atrophy of the alveolar process and pneumatisation of the maxillary sinus. Therefore, alveolar ridge augmentation is frequently necessary before or in conjunction with implant placement. The most commonly used method to augment the maxillary premolar and molar region involves the maxillary sinus floor augmentation applying the lateral window technique with a grafting material. However, the lateral window technique is associated with prolonged patient treatment time and increased morbidity. Thus, osteotome-mediated sinus floor elevation (OSFE) with or without the use of a grafting material has been advocated, when the residual bone height is more than 6 mm.

OSFE involves preparation of implant site through the use of concave osteotomes and elevation of the maxillary sinus floor. The survival of suprastructure and implants after OSFE with or without the use of a grafting material has never been assessed in long-term randomized controlled trials. A long-term study concluded that OSFE with no grafting material is a predictable treatment modality. High short-term implant survival rates after OSFE with or without the use of a grafting material have been reported in systematic reviews. However, the amount of new bone formation after OSFE with the use of a grafting material is significantly higher compared to the use of no grafting material, as documented in a systematic review. Harvesting of autogenous bone graft is associated with risk of donor site morbidity and bone substitutes of natural transplants involves a risk of contamination, activation of host immune system and disease transmission as well as they can be refused by patients for religious reasons or because they are in contrast with chosen lifestyle.

Therefore, the objective of the present study is to test the H0-hypothesis of no difference in the long-term implant treatment outcome after OSFE with Bio-Oss Collagen compared with the use of no grafting material. A total of 40 consecutively healthy patients with a missing posterior tooth in the maxilla will be allocated at random to OSFE with Bio-Oss Collagen or no grafting material and simultaneous implant placement. Clinical and/or radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography (CBCT) will be performed preoperatively, immediate postoperatively, after abutment connection, after prosthetic rehabilitation, one year, three years and five years after loading to assess the long-term 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

  • Survival, Prosthesis
  • Bone Loss
  • Patient Satisfaction

Interventions

PROCEDURE

Sinus floor elevation with a grafting material

The use of grafting material for sinus floor elevation

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2020-04-01
Completion
2020-11-01

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 NCT04618900 on ClinicalTrials.gov