Computer Guided Versus Free Hand Immediate Implant Placement

July 20, 2020 updated by: Safaa Kamel Hussein, Cairo University

Patient Satisfaction and Early Implant Failure of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.

Patients with remaining root or fractured teeth indicated for extraction in the esthetic zone will be recruited to the study. After extraction of the tooth implant will be placed immediately, implants will be placed either by free hand or computer guided technique. patient satisfaction will be evaluated as primary outcome and early implant failure was evaluated as secondary outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

General operative procedures:

Eligible patients will be randomized, at the surgical phase in two groups, study group (in which computer guided implant placement was done using computer aided surgical guide) and comparative group (in which free hand implant placement was done).

Patients of both groups will be subjected to:

Careful clinical examination and medical and dental history taking. CBCT scan will be performed while patients biting on cotton roll to separate the teeth of interest from opposing dentition, moreover cotton rolls will be placed in vestibule for separation of lip and check from teeth of interest.After examination of the CBCT scan, maxillary and mandibular alginate impression will be made for eligible patients.For temporary crown fabrication after the surgery, the tooth or root to be extracted will be modified on the study cast and an artificial tooth will be placed. After that a 2mm hard vacuum sheet will be pressed on the study cast. For the test group (computer guided group), three dimensional (3d) virtual planning of the surgical guide and implant position will be made with the aid of Blue Sky ® implant planning software . After proper selection of implant size, diameter and position, the virtual surgical guide will be exported as a STL file for 3D printing. Before the surgery, adaptation of the surgical guide will be checked on the study cast and a metallic sleeve will be attached at proposed implant position using adhesive.

Intraoperative procedure:

3 days before the surgery, a prophylactic antibiotic will be given to the patient. On the day of surgery, local anaesthesia will be injected and a traumatic extraction of the remaining root or tooth will be performed. For a traumatic extraction, gentle application of a periotome mesio-distally along with slight rotational movement. After extraction, intact labial and palatal socket walls will be checked using periodontal probe for immediate implant placement. For the test group, the computer aided surgical guide will be checked for adaptability and any interference will be removed. After that implant drilling and placement will be performed using the surgical guide. For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls. For both groups implant primary stability will be checked by application of 35 Ncm2 force using torque wrench After that, the final abutment will be screwed in its position and the temporary crown will be made using the vacuum stent, where a chair side tooth coloured autopolymerizing resin will be injected into the vacuum stent at the proposed implant site. Finally, occlusion will be checked for any functional contact in maximum intercuspation and lateral movement. Any contact with the opposing should be removed and the patient will be instructed to avoid eating or incising on the temporary crown for at least two weeks. Seven days later patients will be recalled for inspection and taking postoperative photos, six months thereafter, the patient will receive a definitive crown.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 0000
        • Safaa hussein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with teeth or remaining roots in the esthetic zone and indicated for extraction and replacement with immediate implant.

Sufficient labial bone to avoid labial plate fracture during extraction (at least 1.5-2 mm). This will be confirmed by cone beam computer tomography (CBCT) scan.

Sufficient mesio distal length between the neighbouring natural teeth (at least 7 mm), this will be confirmed on the study cast.

Presence of adjacent teeth to the tooth or remaining root to be extracted.

Exclusion Criteria:

Heavy smokers (more than 2 packs / day). Patients with parafunctional habits (e.g. clenching or bruxism, etc.) Presence of acute infection in the tooth or the remaining root that will be extracted.

Severe overeruption of the opposing teeth to avoid premature contact with the temporary crown during the healing period.

Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with implant placement and its osseointegration (as uncontrolled diabetes, chemotherapy, radiotherapy. Osteonecrosis…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Computer guided immediate implant placement
For the test group, the computer aided surgical guide will be used for implant drilling and placement.
Procedure: Computer guided implant placement
Implant will be placed immediately using computer aided surgical guide
Active Comparator: Free hand immediate implant placement
For the control group, free hand implant drilling and placement will be performed guided by the extraction socket walls.
Procedure: Computer guided implant placement
Implant will be placed immediately using computer aided surgical guide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 0-6 months
Patient satisfaction will be assessed through a questionnaire and each question of the questionnaire will be scored by the patients on 10 cm visual analogue scales (VAS)
0-6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early implant failure
Time Frame: 0-6 months
Early implant failure will be clinically diagnosed by implant loss from mouth which will be detected by visual inspection. Early implant failure will be assessed in the interval between implant placement until functional loading (0-6 months).
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Faculty of Dentistry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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