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

July 29, 2021 updated by: Amr Mohamed Shaarawi, Cairo University

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"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35111
        • Amr Mohamed Shaarawi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alveolar socket preservation with graft and flap surgery
Drug: Alveolar socket preservation with graft and flap surgery
Alveolar socket preservation with xenogenic bone graft and flap surgery
EXPERIMENTAL: Immediate implant placement with bone using flapless surgery
Device: Immediate implant placement with bone using flapless surgery
Immediate implant placement with xenogenic bone graft using flapless surgery
EXPERIMENTAL: Immediate implant placement with bone and flap surgery
Device: Immediate implant placement with bone using flap surgery
Immediate implant placement with xenogenic bone graft using flap surgery
EXPERIMENTAL: Alveolar socket preservation with graft and flapless surgery
Drug: Alveolar socket preservation with graft and flapless surgery
Alveolar socket preservation with xenogenic bone graft and flapless surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone volume changes
Time Frame: 1 year
volumetric bone changes by cone-beam computed tomography
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Ahmed Reda, Phd, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2018

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

March 30, 2021

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (ACTUAL)

October 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • perio2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

I will check with my study chair

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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