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Clinical Trials/NCT03716323
NCT03716323UnknownNot Applicable

Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Premolar Zone With Allograft Versus Xenograft

Cairo University0 sites42 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
42
Primary Endpoint
Marginal Bone Loss

Study Overview

Brief Summary

Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.

Detailed Description

Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
  • •Both sexes.
  • •No intraoral soft and hard tissue pathology.
  • •No systemic condition that contraindicate implant placement.

Exclusion Criteria

  • •Presence of fenestrations or dehiscence of the residual bony walls after extraction.
  • •Heavy smokers more than 20 cigarettes per day.
  • •Patients with systemic disease that may affect normal healing.
  • •Psychiatric problems
  • •Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Arms & Interventions

immediate premolar implant with xenograft and allograft

Experimental

Immediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft

Intervention: immediate premolar implant with xenograft and allograft (Device)

Outcomes

Primary Outcomes

Marginal Bone Loss

Time Frame: 6 months

The amount of marginal bone loss will be measured using cone beam computed tomography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohammed Abdallah AbdelFattah

principal investigator

Cairo University

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