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Completed

NCT Number: NCT04517968

Immediate Implant With Cusomized Healing Abutment

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

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Key information

Conditions

Peri-implant Osteogensis

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 21526, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

immediate implant with customized healing abutment

Other
  • 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.

Primary outcomes

  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:

    • Crestal bone loss.
    • Perapical Bone density.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2020
Registry last updated
Aug 19, 2020

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.