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Clinical Trials/NCT04678674
NCT04678674
Unknown
Not Applicable

Autogenous Tooth Roots for Lateral Alveolar Ridge Augmentation and Staged Implant Placement

St. Catherine Specialty Hospital1 site in 1 country30 target enrollmentJanuary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Atrophy, Alveolar
Sponsor
St. Catherine Specialty Hospital
Enrollment
30
Locations
1
Primary Endpoint
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge
Last Updated
5 years ago

Overview

Brief Summary

A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.

Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.

Registry
clinicaltrials.gov
Start Date
January 15, 2019
End Date
December 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Catherine Specialty Hospital
Responsible Party
Principal Investigator
Principal Investigator

Igor Smojver

Principal Investigator

St. Catherine Specialty Hospital

Eligibility Criteria

Inclusion Criteria

  • age 18 to 60 years
  • candidate for lateral ridge augmentation
  • insufficient bone ridge width at the recipient site for implant placement
  • sufficient bone height at the recipient site for implant placement and (e)
  • healthy oral mucosa
  • at least 2 mm keratinized tissue

Exclusion Criteria

  • general contraindications for dental and/or surgical treatments
  • inflammatory and autoimmune disease of the oral cavity,
  • uncontrolled diabetes (HbA1c \> 7%)
  • history of chemotherapy or radiotherapy within the past five years,
  • previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
  • pregnant or lactating women

Outcomes

Primary Outcomes

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge

Time Frame: 6 months

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans. Measurements were performed to the nearest 0.5mm below the crest using a CBCT.

Secondary Outcomes

  • soft tissue dehiscences(6 months)
  • gain in ridge width (CWg)(6 months)
  • wound infections(6 months)
  • Periimplant tissue stability of augmented sites after prosthetic rehabilitation(12 months)

Study Sites (1)

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