Stability of Patient-specific Root-analogue Implants and Conventional Root-form Implants for Treating Non-restorable Single-rooted Maxillary Teeth

NCT03689933 | Unknown DMC

• 1 other identifier: 28902050100374
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

its a experimental study comparing between the stability of immediate root fomed implant versus the conventional titanium implant

Conditions

Implant Stability; Root Analog Implant; Conventional Root Form Implant; Non Restorabl Teeth

Outcome Measures

Primary Outcomes (1)

• implant stability

  using periotest

  6 months

Study Arms (2)

root analog implant

EXPERIMENTAL

The tooth indicated for extraction will be extracted atraumatically using periotome, socket preservation using Iodoform packing strips, and then optical scanning of the remaining tooth structure with optical scanner will be made to obtain a 3D virtual model, this model will be modified by addition of macro-retentions strictly to the interdental area to avoid any fracture in thin cortical bone, the cervical portion of implant circumference will be decreased by 0.1 to 0.2 mm to avoid pressure resorption of alveolar crest of bone and addition of prepared crown stump for the future crown to be placed.

Device: Root analog implant

conventional stock root-form titanium implant

ACTIVE COMPARATOR

Using a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth.

Device: Root analog implant

Interventions

Root analog implant DEVICE

a custom made root analogue implant made from milled titanium

Also known as: patient specific implant

conventional stock root-form titanium implant; root analog implant

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Single rooted teeth indicated for extraction and immediate implant placement.
• The age of candidates ranges from 21 to 50 years.

You may not qualify if:

• Absence of any disease or systemic complication which might affect osseointegration.
• The cause of extraction mustn't be due to periodontitis or periapical infection.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 1, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: October 1, 2018

Record last verified: 2018-09