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

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ClinicalTrials.gov Identifier: NCT03689933
Recruitment Status : Unknown
Verified September 2018 by Amr mohamed ahmed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Amr mohamed ahmed, Cairo University

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

Condition or disease Intervention/treatment Phase
Implant Stability Root Analog Implant Conventional Root Form Implant Non Restorabl Teeth Device: Root analog implant Not Applicable

Detailed Description:

Patients will be selected from the out-patient clinic according to the inclusion and exclusion criteria, from where the participants will be divided into two equal groups using computer generated random table and the sequence of the random numbers will be only revealed to the Co-supervisor who will report the assigned treatment to the principal investigator.

Immediate placement of root analogue titanium dental implants. All patients in the study group will be radiographed using cone beam computed tomography for diagnosis and evaluating the attachment of the tooth and bone level.

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.

After all additions and adjustments are being made, an STL (stereolithography) extension file followed by milling of the implant from medically grade titanium will be carried out, followed by sandblasting acid etching.

For sterilization, the implant will be washed in a 90% concentration ethanol ultrasonic bath for 10 minutes, followed by packaging and sterilizing in a steam pressure autoclave.

At the day of implant placement, removing of suture and the Iodoform gauze followed by flushing of the extraction socket using saline solution and vigorous curettage of the socket. Then implant placement will be made by hand pressure followed by tapping using mallet.

Implant stability in both groups will be measured using Periotest device. The measuring procedure will be made immediate postoperative, 3 months and 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stability of Patient-specific Root-analogue Implants and Conventional Root-form Implants for Treating Non-restorable Single-rooted Maxillary Teeth
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: root analog implant
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
a custom made root analogue implant made from milled titanium
Other Name: patient specific implant

Active Comparator: conventional stock root-form titanium implant
Using a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth.
Device: Root analog implant
a custom made root analogue implant made from milled titanium
Other Name: patient specific implant




Primary Outcome Measures :
  1. implant stability [ Time Frame: 6 months ]
    using periotest



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Absence of any disease or systemic complication which might affect osseointegration.
  2. The cause of extraction mustn't be due to periodontitis or periapical infection.
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Responsible Party: Amr mohamed ahmed, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03689933    
Other Study ID Numbers: 28902050100374
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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