Computer-guided Versus Free- Hand Immediate Implant Placement (RCT)

June 3, 2020 updated by: Ahmed Kotb, Cairo University

Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.

Patients with fractured anterior teeth indicated for extraction will be recruited to the study. After Extraction of the tooth the socket will be evaluated and if eligible for immediate implant placement, implants will be placed either by free hand or computer guided technique. The pink esthetic score will be evaluated to be the primary 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

After diagnosis and history taking the patient will be informed about the sequences of the trial. If the patient wishes to participate and fulfills the clinical examination inclusion criteria, he/she will be sent to perform a Cone Beam Computer Tomography (CBCT) scan while biting on a cotton roll and placing cotton rolls in the vestibule to separate the teeth of interest from the opposing dentition and lips respectively.

Then the investigator will examine the CBCT to ensure the presence of sufficient labial bone. Only patients with sufficient labial bone (1.5-2 mm) will be included in the study. If the patient has less than 1.5 mm labial bone, he/she won't be eligible for immediate implant placement and would be referred to delayed implant placement.

The eligible patients will be recalled for impression making. The principal investigator will do a vacuum stent (2mm hard) on the obtained study cast for temporary crown fabrication after the surgery. The tooth or root to be extracted will be modified on the cast and an artificial tooth would be placed then the vacuum sheet will be pressed on the cast.

At this appointment (impression making) the patient will choose a sealed envelope containing the allocation either to the computer guided group (test group) or free hand group (control group). The patient's name will be written on the envelope to avoid changing the randomization process.

For the test group, the principal investigator (AK) will do virtual planning using Blue Sky ® implant planning software. Proper implant size and diameter will be used and a virtual surgical guide will be constructed in a Standard Triangulation Language (STL) format and exported to a 3D printing machine for printing. After printing the guide would be rechecked for adaptation on the study cast. A metallic sleeve will be placed and adapted to the surgical guide in the proposed implant site, using adhesive to avoid rotation during surgery.

Surgical procedure:

A prophylactic antibiotic would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome, minimal force and rotational movement.

After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.

In the test group, the computer guided surgical guide will be used for implant drilling and placement following the manufacture's instructions.

While in the control group, after tooth or root extraction implants will be placed free hand guided by the extraction sockets.

Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and re-positioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth colored auto-polymerizing resin will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.

Then occlusion will be checked in maximum intercuspation and lateral movement to avoid any contact with the opposing during the healing period. The patient will be instructed to avoid eating or incising any hard food in the surgical site for at least two weeks.

After a week the patient will be recalled for inspection and postoperative photos to be taken for outcome assessment for both groups. And finally after a period of 6 months the patient would 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, 1234
        • Faculty of Oral and Dental Medicine

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 indicated for extraction in the esthetic zone and eligible for immediate implant placement

    • Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan
    • Presence of adequate mesio-distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast
    • No overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.

Exclusion Criteria:

  • Presence of active sings or symptoms of acute infection in the tooth or the remaining root

    • Heavy smokers (more than 2 packs per day)
    • Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets
    • Patients with poor oral hygiene
    • Pregnant women
    • Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation)

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
  • 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 placement

In the test group, the computer guided surgical guide manufactured using zenith 3D printer (Dentis, Daegu, Korea) will be used for implant drilling and placement (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) following the manufacture's instructions.

Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH, Germany) will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.
Procedure: immediate implant placement

A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement.

After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.
ACTIVE_COMPARATOR: free hand placement
in the control group, the implant will be placed it the socket using free hand technique and according to the manufacturing instruction's (s-Clean Tapered Implants, Dentis Co., Ltd., Woram-Dong, Dalseo-Gu, Daegu, South Korea) . The implants will be placed guided by the socket of the root. Then in implants with primary stability > 35 Ncm2, the final abutment will be placed and any further adjustment would be done immediately in the lab and repositioned in place. Then the vacuum stent will be checked in its place again intraorally, then a chair side tooth coloured autopolymerizing resin (Structur 2 SC / QM,VOCO GmbH,Germany)will be injected into the vacuum sheet corresponding to the implant site to construct the temporary crown.
Procedure: immediate implant placement

A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement.

After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement.

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
Pink Esthetic Score (PES)
Time Frame: 1 week postoperative to surgery
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
1 week postoperative to surgery
Pink Esthetic Score (PES)
Time Frame: 1 week postoperative to definitive crown
a scoring system of five points are to be checked and evaluated where 0=incomplete; 1= partially present; 2= completely present
1 week postoperative to definitive crown

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
Gingival recession
Time Frame: 1 week and 6 month postoperatively
yes/no
1 week and 6 month postoperatively

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 15, 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 1, 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 6, 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 6, 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 7, 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.
June 5, 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.
June 3, 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.
June 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.
  • Prosthodontic Department

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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