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

Not Applicable

• Conditions: Badly Decayed Teeth
• Interventions: Device: autograft mixed with xenograft bone

• Registration Number: NCT04096209
• Lead Sponsor: Cairo University

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

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Last Update Submitted: 2019-09-18
• Study First Posted: 2019-09-19
• Last Update Posted: 2019-09-19
• Study Start: 2019-09-30
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Graft-less and grafting using xenograft and autograft	autograft mixed with xenograft bone	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

Primary Outcome Measures

Name	Time	Method
Implant stability	4-6 months	implant stability will be measured using osstell

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt