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OpenTrials
Completed

NCT Number: NCT03211819

Computer-guided Versus Free- Hand Immediate Implant Placement

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine

Cairo, 1234, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immediate Implant Placement

Procedure

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Gingival recession

    Time frame: 1 week and 6 month postoperatively

    yes/no

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 7, 2017
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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