Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement

July 17, 2024 updated by: Osama Atef Elshahat Attia, Cairo University

Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement in the Maxillary Premolar Area With or Without Loading: A Randomized Controlled Clinical Trial

The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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
      • Cairo, Egypt
        • Cairo University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.

    2. Patients with healthy systemic condition. 3. Patients aged from 20 to 45 years old. 4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014) 5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014) 6. Good oral hygiene.(Wiesner et al., 2010) 7. Accepts one year follow-up period (cooperative patients) Patient provides an informed consent.

    8. Adequate Inter-arch space for implant placement. 9. Favorable occlusion (no traumatic occlusion)

Exclusion Criteria:

- 1. Patients with signs of acute infection related to the area of interest. 2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).

3. Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Implants with loading
Procedure: immediate implant placement with or without loading
immediate implant placement with or without loading
Active Comparator: Immediate Implants without loading
Procedure: immediate implant placement with or without loading
immediate implant placement with or without loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height of alveolar bone crest
Time Frame: 6 months
After the implants are placed, a series of digital radiographs are obtained at 0 , 3, and 6 months duration to study the changes in the amount of crestal bone level.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability
Time Frame: 6 months
Implant stability quotient (ISQ) values were measured with an Osstell® (Integration Diagnostics AB, Gothenburg, Sweden)
6 months
Alveolar bone width
Time Frame: 6 months
(CBCT) images are used for evaluation of alveolar bone width around all implant sides all over. At 0. 3, 6 month postoperative by using superimposition and subtraction method
6 months
post-surgical patient satisfaction
Time Frame: 6 months
Post-Surgical Patient Satisfaction Questionnaire (PSPSQ) composed of 3 questions is filled by the patient and numerical score is obtained
6 months

Collaborators and Investigators

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

Sponsor

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)

July 16, 2023

Primary Completion (Actual)

July 16, 2024

Study Completion (Actual)

July 16, 2024

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 15-7-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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