Immediate Implant With Cusomized Healing Abutment

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: Peri-implant Osteogensis
• Intervention / Treatment: Other: immediate implant with customized healing abutment

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

Study Locations

• Egypt
  • Alexandria, Egypt, 21526
    • Faculty of Dentistry

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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.	at 3rd, 6th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1st day, 1 week, 4 weeks, 6 weeks, 12 weeks and after 6 months

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

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