Clinical trial NCT04096209: Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft
Official title: The Effect on Dental Implant Stability With and Without Using 1:1 Mixture of Autogenous Bone and Anorganic Bovine Bone Minerals Particulates in Immediate Implant Placement in the Dental Esthetic Zone (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Badly Decayed Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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).

Primary outcomes:
measure: Implant stability
timeFrame: 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: