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

NCT ID: NCT03689933

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2020-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Root analog implant

Intervention Type: DEVICE

a custom made root analogue implant made from milled titanium

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.

Group Type: ACTIVE_COMPARATOR

Root analog implant

Intervention Type: DEVICE

a custom made root analogue implant made from milled titanium

Interventions

Root analog implant

a custom made root analogue implant made from milled titanium

Intervention Type: DEVICE

Other Intervention Names

patient specific implant

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr mohamed ahmed

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

28902050100374

Identifier Type: -

Identifier Source: org_study_id