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Clinical Trials/NCT03690973
NCT03690973
Completed
Phase 4

Evaluation of Bone Changes of The Extraction Sockets After Immediate Implant or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone "Randomized Controlled Clinical Trial"

Cairo University1 site in 1 country32 target enrollmentSeptember 30, 2018

Overview

Phase
Phase 4
Intervention
Immediate implant placement with bone using flap surgery
Conditions
Alveolar Socket Preservation
Sponsor
Cairo University
Enrollment
32
Locations
1
Primary Endpoint
Bone volume changes
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The amount of hard tissue resorption following tooth extraction involves prosthetically driven implant placement; therefore, the development of ridge preservation techniques that result in less alveolar bone loss is of great interest, Alveolar ridge preservation are indicated to decrease the loss of ridge volume that follows tooth extraction.However, they do not prevent bone resorption because, depending on the technique.The protocol of placing implants immediately upon tooth extraction has been introduced into clinical practice which aims to preserve the socket from resorption, also immediate implant satisfy the patient as it decrease the time for crown insertion in addition to that it has a good survival.There is not adequate research data to clearly demonstrate that flapless socket preservation techniques are superior to techniques that involve raising a flap, but an animal study reported that the detachment of the periosteum from the buccal site of the ridge leads to an increase of the resorption rate, resulting in an increase of the ridge resorption

Detailed Description

Socket preservation procedures have been performed to preserve hard and soft tissue volume, which can be partially lost after tooth removal. These procedures allow for wider and longer implant placement compared with non-augmented sockets and reduce the need for simultaneous augmentation procedures at the time of implant placement.It is expected that immediate implant avoid crestal resorption in the fresh extraction socket in humans also immediate installation at the time of extraction offers potential advantages for both practitioners and patients. It allows a decrease in treatment time and may result in an increase in patient satisfaction.Also it is expected that flapless procedure include maintenance of the buccal keratinized gingival , and prevention of alterations to the gingival contours and migration of the mucogingival junction that are often experienced after raising a flap

Registry
clinicaltrials.gov
Start Date
September 30, 2018
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Mohamed Shaarawi

Teaching assistant

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Age: Above 18 years.
  • Patients with single non-restorable teeth in anterior or premolar area.
  • Patients with adequate bone volume for the dental implant procedure.
  • Patients with good oral hygiene
  • Patient consent approval and signing.

Exclusion Criteria

  • Heavy smokers.
  • Systemic disease that contraindicates surgical implant placement
  • Presence of any acute pathosis at the site of surgery.
  • Patients with thin alveolar ridge.

Arms & Interventions

Immediate implant placement with bone and flap surgery

Intervention: Immediate implant placement with bone using flap surgery

Alveolar socket preservation with graft and flapless surgery

Intervention: Alveolar socket preservation with graft and flapless surgery

Alveolar socket preservation with graft and flap surgery

Intervention: Alveolar socket preservation with graft and flap surgery

Immediate implant placement with bone using flapless surgery

Intervention: Immediate implant placement with bone using flapless surgery

Outcomes

Primary Outcomes

Bone volume changes

Time Frame: 1 year

volumetric bone changes by cone-beam computed tomography

Study Sites (1)

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