Immediate Implant With Cusomized Healing Abutment

August 17, 2020 updated by: Hams Hamed Abdelrahman

Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)

evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.

The aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.

Study Type

Interventional

Enrollment (Actual)

8

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
      • Alexandria, Egypt, 21526
        • Faculty of Dentistry

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age range: 20 - 40 years
  • Good oral hygiene
  • A freshly extracted socket in the mandibular molar area.
  • The gap between the implant and the bone will be at least 3-4 mm.

Exclusion criteria:

  • Acute infection (periodontitis or mucosal infection)
  • Patients on radiotherapy or chemotherapy.
  • Alcohol or drug abuse.
  • Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
  • Smokers.
  • Parafunctional habits.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate implant with customized healing abutment
Other: immediate implant with customized healing abutment
  • All patients will be operated under local anesthesia.
  • Atraumatic extraction of the remaining root or tooth will be achieved.
  • A careful curettage of the socket will be performed if any granulation tissue is present.
  • Sequential drilling of the osteotomy site with copious irrigation will be done
  • The Implant is secured in place using a torque wrench.
  • Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket.
  • Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends.
  • The abutment will be attached to the implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in bone density
Time Frame: at 3rd, 6th months

Cone beam CT will be taken immediately and 6 months postoperatively On Demand 3d software** is used to assess:

  1. Crestal bone loss.
  2. Perapical Bone density.
at 3rd, 6th months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain
Time Frame: 1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months
The patients will be examined using the Visual Analogue Scale (VAS). the scale is from 0-10 0 =no pain 10= most severe pain
1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

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)

October 1, 2019

Primary Completion (Actual)

February 3, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • immediate implants

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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