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

Not Applicable

• Conditions: Implant Stability; Root Analog Implant; Non Restorabl Teeth; Conventional Root Form Implant
• Interventions: Device: Root analog implant

• Registration Number: NCT03689933
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-27
• Last Update Submitted: 2018-09-27
• Study First Posted: 2018-10-01
• Last Update Posted: 2018-10-01
• Study Start: 2018-11
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
root analog implant	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.
conventional stock root-form titanium implant	Root analog implant	Using a conventional implant as a comparator as it's the gold stander in restoring the non-restorable teeth.

Primary Outcome Measures

Name	Time	Method
implant stability	6 months	using periotest