Osteotome-mediated Sinus Floor Elevation With or Without Grafting Material

NCT04618900 | Completed

• 1 other identifier: Aalborg University Hospital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alveolar ridge augmentation; Maxillary sinus floor elevation; Bone substitute

Outcome Measures

Primary Outcomes (1)

• Survival of suprastructures and implants

  Loss of suprastructures and dental implants

  1-year

Secondary Outcomes (1)

• Volumetric stability of the grafting material

  1-year

Study Arms (2)

Osteotome-mediated sinus floor elevation with Bio-Oss collagen

EXPERIMENTAL

Sinus floor elevation with a grafting material (Bio-Oss collagen)

Procedure: Sinus floor elevation with a grafting material

Osteotome-mediated sinus floor elevation with no grafting material

PLACEBO COMPARATOR

Sinus floor elevation with no grafting material

Procedure: Sinus floor elevation with a grafting material

Interventions

Sinus floor elevation with a grafting material PROCEDURE

The use of grafting material for sinus floor elevation

Osteotome-mediated sinus floor elevation with Bio-Oss collagen; Osteotome-mediated sinus floor elevation with no grafting material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females of ≥20 years of age.
• Missing one posterior maxillary tooth (premolar or molar) for more than 4 months.
• Residual vertical alveolar bone height of the maxillary alveolar process ≤ 6-10mm ≤.
• Width of the alveolar maxillary process ≥6.5 mm.
• Mandibular occluding teeth.
• Should be able to speak and understand Danish.

You may not qualify if:

• Medical contraindications to implant therapy e.g. recent myocardial infarction and cerebrovascular accident, recent valvular prosthesis surgery, immunosuppression, bleeding issues, active treatment of malignancy, drug abuse, psychiatric illness and intravenous bisphosphonate treatment.
• Irradiated jaw bones (radiotherapy treatment).
• Full mouth plaque score \>25%.
• Progressive marginal periodontitis in the maxilla and mandible.
• 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

Related Publications (1)

• Starch-Jensen T, Bruun NH, Spin-Neto R. Endo-sinus bone gain following osteotome-mediated sinus floor elevation with Bio-Oss Collagen compared with no grafting material: a one-year single-blind randomized controlled trial. Int J Oral Maxillofac Surg. 2023 Nov;52(11):1205-1215. doi: 10.1016/j.ijom.2023.03.009. Epub 2023 Mar 29.

  PMID: 36997448 DERIVED

MeSH Terms

Conditions

Prosthesis Failure; Bone Diseases, Metabolic; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Healthy patients in need of dental implant in the posterior part of the maxilla
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DDS, PhD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: November 22, 2019
• Primary Completion: April 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)