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Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Badly Decayed Teeth

Treatments

Device: autograft mixed with xenograft bone

Study type

Interventional

Funder types

Other

Identifiers

NCT04096209
CairoUimplant 2

Details and patient eligibility

About

Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow.

However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.

Full description

Not using a grafting material in the jumping gap was chosen as a comparator as it's the standard procedure usually applied and showed high success rates. This should allow us to assess whether the chosen grafting material would have a positive influence on the study outcomes as compared to it.

Intraoral and extraoral autologous bone grafts could be considered as the "Gold standard" pre-prosthetic dentoalveolar reconstruction of atrophic jaws with cortico-cancellous bone grafts from intraoral and/or extraoral donor sites as a predictable technique for the facilitation of dental rehabilitation of atrophic ridges, associated with high bone survival rate and long term implant success. Autogenous bone corresponds to bone graft obtained from the same individual. It is considered the gold standard for filling of bone defects since it allows (I) osseointegration: direct contact with bone tissue without fibrous tissue ; (II) osteoconduction: support to bone growth (III) osteoinduction: differentiation of mesenchymal cells of surrounding tissue (receptor site) into osteoblastic cells ; and (IV) osteogenesis: bone neoformation by osteoblastic cells present in the graft material. Although few mature osteoblasts survive to grafting, precursor cells are responsible for the osteogenic potential

Enrollment

26 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 20-60 years
  • Both sexes
  • non-restorable maxillary incisors, canine and premolars
  • Good oral hygiene
  • Adequate bone height apical to the alveolus of the failing tooth

Exclusion criteria

  • Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
  • Bad oral hygiene
  • Bruxism, clenching, deep bite, edge to edge and abnormal habits
  • Non-treated periodontal diseases
  • Pregnancy and smokers
  • Severe infection
  • Absence of labial plate of bone (Fenestration, dehiscence).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Graft-less and grafting using xenograft and autograft
Experimental group
Description:
Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone
Treatment:
Device: autograft mixed with xenograft bone

Trial contacts and locations

1

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Central trial contact

Mohammed Atef, PhD; Sherine Osama El-Ebiary, BDS

Data sourced from clinicaltrials.gov

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