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Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone

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ClinicalTrials.gov Identifier: NCT03741036
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Mohamed tarek mohamed youssif omar, Cairo University

Brief Summary:
compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization

Condition or disease Intervention/treatment Phase
Dental Implant Failed Procedure: Autogenous bone graft as space filling in immidiate implant placment Procedure: Deprotinized bovien as space filling in immidate implant placement Procedure: Nano-hydroxiapatite alloplast in immidiate implant placement Not Applicable

Detailed Description:

Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score [PES]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow‐up of at least 12 months.

The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.

Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.

Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Implant Placement With Provisionalization Using Autogenous Bone Graft Particulates vs Deproteinized Bovine Bone vs Nano-hydroxyapatite Alloplast as a Space Filling Material in the Maxillary Esthetic Zone
Estimated Study Start Date : November 27, 2018
Estimated Primary Completion Date : July 27, 2019
Estimated Study Completion Date : August 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Active Comparator: autogenous bone graft as a space filling material
Autogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket
Procedure: Autogenous bone graft as space filling in immidiate implant placment
  • The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft)
  • Patients will be subjected to CBCT (diagnostic for upper arch).
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • The procedure will be carried out flapless.
  • In the study group: Atraumatic extraction
  • The extraction socket will be evaluated for absence of any fenestration or granulation tissues

Active Comparator: deproteinized bovine as a space filling material
Granules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm.
Procedure: Deprotinized bovien as space filling in immidate implant placement
  • The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material)
  • Patients will be subjected to CBCT (diagnostic for upper arch).
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • The procedure will be carried out flapless.
  • In the study group: Atraumatic extraction
  • The extraction socket will be evaluated for absence of any fenestration or granulation tissues

Active Comparator: nano-hydroxyapatite alloplast as a space filling material
The patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket
Procedure: Nano-hydroxiapatite alloplast in immidiate implant placement
  • The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material )
  • Patients will be subjected to CBCT (diagnostic for upper arch).
  • Local anesthesia will be given to the patient.
  • Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
  • The procedure will be carried out flapless.
  • In the study group: Atraumatic extraction
  • The extraction socket will be evaluated for absence of any fenestration or granulation tissues




Primary Outcome Measures :
  1. Primary stability (marginal bone loss) [ Time Frame: 3 months ]
    measure device (osstell )



Information from the National Library of Medicine

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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:

  • Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
  • Both sexes.
  • No intraoral soft and hard tissue pathology
  • No systemic condition that contraindicate implant placemen

Exclusion Criteria:

  • Heavy smokers more than 20 cigarettes per day.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

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): NCT03741036


Contacts
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Contact: mohamed tarek, master 01114951862 mtm.omar@yahoo.com
Contact: mohamed tarek, master 01060344568 MOHAMED_YUSSIF@dentistry.cu.edu.eg

Locations
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Egypt
Cairo University Active, not recruiting
Cairo, Egypt
Mohamed tarek Recruiting
Cairo, Egypt
Contact: Mohamed Tarek    00201114951862    Mtm.9mar@yahoo.com   
Sponsors and Collaborators
Mohamed tarek mohamed youssif omar
Cairo University

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Responsible Party: Mohamed tarek mohamed youssif omar, Researcher, Cairo University
ClinicalTrials.gov Identifier: NCT03741036     History of Changes
Other Study ID Numbers: CEBD-CU-27-7-2018
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Mohamed tarek mohamed youssif omar, Cairo University:
immidiate
dental implant
immidiate provisionalization
bone graft