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Immediate Implant With Cusomized Healing Abutment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04517968
Recruitment Status : Completed
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hams Hamed Abdelrahman, Alexandria University

Study Description
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Brief Summary:
evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

Condition or disease Intervention/treatment Phase
Peri-implant Osteogensis Other: immediate implant with customized healing abutment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Immediate Implant Placement Using Customized Healing Abutment (Clinical Study)
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : June 15, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517968


Locations
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Egypt
Faculty of Dentistry
Alexandria, Egypt, 21526
Sponsors and Collaborators
Hams Hamed Abdelrahman
More Information
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Responsible Party: Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier: NCT04517968    
Other Study ID Numbers: Immediate implants
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No