Maxillary Sinus Floor Augmentation in Diabetic Patients

NCT04543630 | Not Yet Recruiting DMC

• 1 other identifier: N-20200009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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

Jaw, Edentulous, Partially; Diabetes

Keywords

Implant Dentistry; Sinus floor augmentation; Autogenous bone; Platelet-rich fibrin; Diabetes

Outcome Measures

Primary Outcomes (3)

• Implant survival

  Presence of implant at follow-up

  1 year

• Implant survival

  Presence of implant at follow-up

  3 years

• Implant survival

  Presence of implant at follow-up

  5 years

Secondary Outcomes (3)

• Volumetrical stability of the graft material

  1, 3 and 5 years

• Peri-implant marginal bone level

  1, 3 and 5 years

• Effect of implant placement and graft material on hematological and inflammatory parameters

  Pre-surgery, immediately after surgery, Baseline, 1, 3 and 5 years

Study Arms (2)

Particulated autogenous bone

ACTIVE COMPARATOR

Particulated autogenous bone is considered the gold standard for sinus floor augmentation. The bone will be harvested locally

Procedure: Sinus floor augmentation

Advanced platelet-rich fibrin

EXPERIMENTAL

Advanced platelet-rich fibrin will be be obtained through a blood sample from the participant

Procedure: Sinus floor augmentation

Interventions

Sinus floor augmentation PROCEDURE

Sinus floor augmentaion using the lateral window technique

Advanced platelet-rich fibrin; Particulated autogenous bone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥20 years.
• Insulin-dependent diabetes with missing posterior maxillary tooth/teeth.
• Residual bone height of the maxillary alveolar process between 4 and 7 mm.
• Width of the alveolar process ≥6.5 mm.
• Presence of mandibular occluding teeth.
• Plasma glucose levels below 7.8 mmol/l or 140 mg/dl.

You may not qualify if:

• Contraindications to implant therapy.
• Full mouth plaque score \>25%.
• Progressive periodontitis.
• Acute infection in the area intended for implant placement.
• Parafunction, bruxism, or clenching.
• Psychiatric problems or unrealistic expectations.
• Smoking. Previous smoker will not be excluded.
• Pregnancy

Sponsors & Collaborators

• University of Copenhagen: lead
• Copenhagen University Hospital at Herlev: collaborator
• Aalborg University Hospital: collaborator

Study Sites (3)

Aalborg University Hospital, Dept. of Oral & Maxillofacial Surgery

Aalborg, 9800, Denmark

Location

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

University of Copenhagen, School of Dental Medicine

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially; Diabetes Mellitus

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Jaw, Edentulous; Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Central Study Contacts

Simon S Jensen, Professor

CONTACT

+4535333052; simon.storgaard.jensen@sund.ku.dk

Thomas Starch-Jensen, Professor

CONTACT

+4523266370; thomas.jensen@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to which arm the individual participant was treated under
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Well-controlled diabetic patients with indication of sinus floor augmentation to allow placement of a dental implant in the posterior maxilla will be randomized to one of two sinus augmentation protocols: particulated autogenous bone or advanced platelet-rich fibrin

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: December 1, 2020
• Primary Completion: June 1, 2022
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)