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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211819
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Kotb, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Implant Procedure: immediate implant placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: due to the nature of the trial only the outcome assessror will be masked from the intervention or control group
Primary Purpose: Treatment
Official Title: Esthetic Outcome of Computer-guided Versus Free- Hand Immediate Implant Placement in Fresh Extraction Sockets in Esthetic Zone, a Randomized Clinical Trial.
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 1, 2020

Arm Intervention/treatment
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.





Primary Outcome Measures :
  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 Outcome Measures :
  1. Gingival recession [ Time Frame: 1 week and 6 month postoperatively ]
    yes/no



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211819


Locations
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Egypt
Faculty of Oral and Dental Medicine
Cairo, Egypt, 1234
Sponsors and Collaborators
Cairo University
Publications:
Arısan, V., Karabuda, C. Z., Mumcu, E. & Özdemir, T. Implant Positioning Errors in Freehand and Computer-Aided Placement Methods: A Single-Blind Clinical Comparative Study. Int. J. Oral Maxillofac. Implants 28, 190-204 (2013). 2. Khzam, N. et al. Systematic Review of Soft Tissue Alterations and Esthetic Outcomes Following Immediate Implant Placement and Restoration of Single Implants in the Anterior Maxilla. J. Periodontol. 86, 1321-30 (2015). 3. SCHROPP, L. & ISIDOR, F. Timing of implant placement relative to tooth extraction. J. Oral Rehabil. 35, 33-43 (2008). 4. Al-Sabbagh, M. & Kutkut, A. Immediate Implant Placement. Dent. Clin. North Am. 59, 73-95 (2015).

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Responsible Party: Ahmed Kotb, Assisstant Lecturer- Prosthodontic Department- Faculty of Dentistry- Principle Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03211819    
Other Study ID Numbers: Prosthodontic Department
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Kotb, Cairo University:
immediate
esthetics