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Trial record 23 of 119 for:    ZIRCONIUM

Patient Satisfaction, Peri-implant Parameters and Crestal Bone Evaluation of PEEK (Polyetheretherketone) Abutments Versus Zirconium Abutments Restored With PEEK Based Superstructure

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ClinicalTrials.gov Identifier: NCT03714074
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Amr Ali youssef, Cairo University

Brief Summary:
The aim of the study is to evaluate the patients` satisfaction, peri-implant parameters (bleeding on probing, probing depth and plaque index) and crestal bone resorption of implants restored with PEEK abutments restored with PEEK superstructure compared to implants restored with zirconia abutments with PEEK superstructure.the NULL HYPOTHESIS;There is no difference between the two groups

Condition or disease Intervention/treatment Phase
Patients Satisfaction Device: PEEK implant abutment Device: Zirconia abutment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Satisfaction, Peri-implant Parameters and Crestal Bone Evaluation of PEEK (Polyetheretherketone) Abutments Versus Zirconium Abutments Restored With PEEK Based Superstructure: A Randomized Clinical Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: PEEK abutment
PEEK abutment restored with PEEK superstructure
Device: PEEK implant abutment
Implants will be restored with abutments made from polyetheretherketone (PEEK) abutments and a PEEK superstructure
Other Name: Polyetheretherketone abutments

Experimental: Zirconia abutment
zirconia abutment restored with PEEK superstructure
Device: Zirconia abutment
Imolants will be restored with zirconia abutments and a PEEK superstructure
Other Name: esthetic abutment, hybrid abutment, all ceramic abutment




Primary Outcome Measures :
  1. change in Patients satisfaction: VAS [ Time Frame: baseline, 3, 6 and 12 months (1 year) ]
    Visual analogue scale (VAS) a numerical scale from 0 - 10 , 0 = not satisfied and 10 = highly satisfied


Secondary Outcome Measures :
  1. Change in bleeding in probing [ Time Frame: baseline, 3 , 6 and 12 months (1 year) ]
    inserting periodontal probe in gingival sulcus to detect bleeding (yes or no)depth (millimeters)

  2. Change in periodontal probing depth [ Time Frame: baseline, 3 , 6 and 12 months (1 year) ]
    inserting a graduated periodontal probe to detect presence or absence of pockets (yes or No)

  3. Change in Plaque accumilation [ Time Frame: baseline, 3 , 6 and 12 months (1 year) ]
    visual inspection for plaque accumilation (yes or No)


Other Outcome Measures:
  1. change in crestal bone resorption [ Time Frame: baseline, 3 , 6 and 12 months (1 year) ]
    in millimeters by superimposition of standerdized radiographs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. patients above 18 years old
  2. Patients able to read and sign the informed consent.
  3. Medically free patients or with controlled systemic condition.
  4. Missing tooth/teeth in the esthetic zone
  5. Minimum bucco-lingual bone width of 6mm, evaluated using CBCT.
  6. Good oral hygiene and favourable occlusion
  7. Cooperative and motivated Patients.

Exclusion Criteria:

  1. Under 18 years old
  2. Illiterate, unable of comprehending or signing the informed consent form
  3. Uncontrolled systemic disease (e.g. Diabetes or hypertension) or debilitated health condition
  4. Pregnancy
  5. Poor oral hygiene or unfavorable occlusion
  6. Uncooperative, not willing to return for follow up visits
  7. Insufficient bone quantity or quality for implant placement

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): NCT03714074


Contacts
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Contact: Amr A Youssef, BDs 012-2489-5408 amr.youssef@dentistry.cu.edu.eg
Contact: Karim A Rabie, Phd karimaboubakr@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Amina Zaki, Professor Cairo University

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Responsible Party: Amr Ali youssef, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03714074     History of Changes
Other Study ID Numbers: CEBD-CU-2018-09-27
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 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