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CompletedNCT04517968Updated Aug 19, 2020

Immediate Implant With Cusomized Healing Abutment

An interventional study of immediate implant with customized healing abutment in Peri-implant Osteogensis, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Peri-implant Osteogensis
03

In context

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    immediate implant with customized healing abutment

    Other: immediate implant with customized healing abutment

Interventions

  • Otherimmediate 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.

06

What researchers measure

Primary outcomes

  1. change in bone density

    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.

    Time frame: at 3rd, 6th months

Secondary outcomes

  1. Change in pain

    The patients will be examined using the Visual Analogue Scale (VAS). the scale is from 0-10 0 =no pain 10= most severe pain

    Time frame: 1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months

07

Study locations

1 site
  • Faculty of Dentistry
    Alexandria, 21526, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04517968
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Aug 19, 2020
Start date
Oct 1, 2019
Primary completion
Feb 3, 2020
Completion
Jun 15, 2020
Last update
Aug 19, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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