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

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04096209
Enrollment
26
Registered
2019-09-19
Start date
2019-09-30
Completion date
2020-06-30
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Badly Decayed Teeth

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

Interventions

DEVICEautograft mixed with xenograft bone

Eligible patients will be randomized in equal proportions between control group (immediate implant placement without bone grafts in the jumping gap) and study group (immediate implant placement with a mixture of Xenograft and autogenous bone placed in the jumping gap). All patients will be evaluated by proper history taking and thorough clinical and radio graphical examination and assessed according to the inclusion and exclusion criteria. Patients of both groups will be subjected to Cone beam Computed tomography (CBCT). Primary impression will be taken, a study model will then be poured and then waxing up will be performed. Patients will be instructed to rinse with chlorhexidine 0.1% mouthwash. Articaine 4% (1:100,000) local anesthesia will be given to the patient. Atraumatic extraction of the tooth or remaining root using No. 15c lancet and periotome

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Implant stability4-6 monthsimplant stability will be measured using osstell

Countries

Egypt

Contacts

Primary ContactSherine Osama El-Ebiary, BDS
sherine.ebiary@gmail.com01285594066
Backup ContactMohammed Atef, PhD
zokasur@gmail.com01009612708

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026