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Clinical Trials/NCT05047861
NCT05047861UnknownNot Applicable

Evaluation of Implant Placement in Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast (Controlled Clinical and Radiographic Study)

Hams Hamed Abdelrahman1 site in 1 country8 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
8
Locations
1
Primary Endpoint
change in bone height

Study Overview

Brief Summary

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.

This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
  • Intact labial/buccal periodontal tissues.
  • Sufficient bone volume to allow placement of an implant.
  • Non-Smoker
  • Ability to read and sign an informed consent form

Exclusion Criteria

  • A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
  • Untreated periodontal disease. [15,18]
  • Vertical root fractures on the buccal aspect. [26]
  • Tooth /teeth with horizontal fractures below bone level. [26]
  • Tooth /teeth with external or internal resorptions.

Arms & Interventions

Study group

Experimental

patients will receive the implant in the previously preserved socket using Socket shield technique with Alloplastic graft material

Intervention: socket shield technique with autogenous dentin graft (Procedure)

Control group

Active Comparator

patients will receive the implant in the previously preserved socket shield with Autogenous dentin graft

Intervention: socket shield technique with alloplast graft (Procedure)

Outcomes

Primary Outcomes

change in bone height

Time Frame: at baseline and 3 months

it will be measured using CBCT

Change in implant stability

Time Frame: immeditely and at 3 months

it will be measured using Osstell ISQ, or Implant Stability Quotient, is a scale from 1 to 100 and is a measure of the stability of an implant. High stability means \>70 ISQ, between 60-69 is medium stability and \< 60 ISQ is considered as low stability.

change in bone density

Time Frame: at baseline and 3 months

it will be measured using CBCT

change in Labio/Bucco-Palatal width

Time Frame: at baseline and 3 months

it will be measured using CBCT

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hams Hamed Abdelrahman
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

Study Sites (1)

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