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Completed

NCT Number: NCT03690973

Evaluation of Bone Changes After Immediate Implant Placement or Socket Preservation With or Without Surgical Flap in The Aesthetic Zone

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

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Key information

Conditions

Alveolar Socket Preservation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amr Mohamed Shaarawi

Al Mansurah, 35111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alveolar socket preservation with graft and flap surgery

Drug

Alveolar socket preservation with xenogenic bone graft and flap surgery

Immediate implant placement with bone using flapless surgery

Device

Immediate implant placement with xenogenic bone graft using flapless surgery

Immediate implant placement with bone using flap surgery

Device

Immediate implant placement with xenogenic bone graft using flap surgery

Alveolar socket preservation with graft and flapless surgery

Drug

Alveolar socket preservation with xenogenic bone graft and flapless surgery

Primary outcomes

  1. Bone volume changes

    Time frame: 1 year

    volumetric bone changes by cone-beam computed tomography

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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"

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 1, 2018
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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