Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201803003201320 Date of Approval: 15/03/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Implant Supported and Tooth-Implant Supported versus Teeth Supported Zirconia : Evaluation of Wear, Internal Adaptation and Marginal accuracy
Official scientific title Implant Supported and Tooth-Implant Supported versus Teeth Supported Zirconia Fixed Restorations: Evaluation of Wear, Internal Adaptation and Marginal Accuracy
Brief summary describing the background and objectives of the trial Differences in composition and physical properties of tooth substances and restorative materials result in differential wear with time. This mismatch of wear rate can result in either excessive wear of the restorative material or the opposing dentition and may subsequently result in occlusal destabilization, tooth sensitivity, decrease in vertical dimension or loss of esthetics. Therefore, the effect of restorative materials on the wear of natural enamel should be studied. Zirconia, one of the more recently introduced materials is a crystalline dioxide of zirconium, and its most useful mechanical properties are obtained in multiphase material known as partially stabilized zirconia. High-strength zirconia is generally layered with veneering porcelain, which is prone to fracture because of weak interface bonding. Therefore, zirconia-fixed dental prostheses without veneering ceramic, called monolithic zirconia prostheses, are currently popular. The purpose of this study is intended to: 1.To evaluate the wear of implant-supported, tooth-implant supported and teeth-supported monolithic zirconia fixed dental prosthesis. 2.To evaluate the internal adaptation and marginal accuracy of implant-supported, tooth-implant supported and teeth-supported monolithic zirconia fixed dental prosthesis.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health,Wear, Internal Adaptation and Marginal Accuracy
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 17/05/2016
Actual trial start date 06/06/2016
Anticipated date of last follow up 06/06/2018
Actual Last follow-up date 01/12/2017
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 29
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group implants- supported monolithic zirconia and teeth-implant supported monolithic zirconia thee unit monolithic zorconia derived it's support from either two inserted implants or from mesial natural tooth and distsal inserted implant .we compare and evaluate how these interventions will work on enamel wear and marginal accuracy 20
Control Group teeth-supported monolithic zirconia thee unit monolithic zorconia derived it's support from conventional natural teeth and how this will be reflected on wear and marginal accuracy 9 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.At least 18 years old, can read and sign the informed consent document. 2.Physically and psychologically able to tolerate conventional restorative procedures. 3.Have no any systemic disorders. 4.Patients with teeth missing problems indicated for implant supported fixed restoration. 5.Be willing to return for follow-up examinations and evaluation. 1.Patients with poor oral hygiene and motivation. 2.Pregnant women. 3.Patient under drug therapy. 4.Psychiatric problems or unrealistic expectations. 5.Lack of opposite occluding dentition in the area intended for restoration. ¿6.¿Heavy Smoker patients.¿ 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/05/2016 Ethics committe of Mansoura University
Ethics Committee Address
Street address City Postal code Country
Mansoura University Building, Mansoura City mansoura city 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome evaluate marginal accuracy 3 months 6 months 9 months 12 months
Primary Outcome Evaluate natural enamel wear 3 months 6 months 9 months 12 months
Secondary Outcome Evaluate internal adaptation 3 months 6 months 9 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
College of Dentistry, Mansoura University Buliding Algamea st. Mansoura City 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal 9 Abdulsattar Amen st. Mansoura City 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fixed Prosthodontic Department, Faculty of dentistry Mansoura University Buliding Mansoura City 002 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Mohammed Hamid Ghazy Mansoura University Buliding Mansoura City 002 Egypt
Prof. Dr. Manal Abo Madina Mansoura University Buliding Mansoura City 002 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdulsattar Hasan Naji Ali Albaadani abdulsattarhasan@gmail.com 00201149521992 31 almasan st. hadaek elmaadi
City Postal code Country Position/Affiliation
Cairo 002 Egypt Doctorate researcher
Role Name Email Phone Street address
Public Enquiries Prof. Dr Manal Abo Madina a711482260@gmail.com 00201280308033 31 almasan st. hadaek elmaadi
City Postal code Country Position/Affiliation
Cairo 002 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries mohammed hamid Ghazy mghazy@mans.edu.eg 00201005025275 almahata square, dr,ghazy clinic
City Postal code Country Position/Affiliation
Mansoura 002 Egypt Professor and Head of Fixed prosthodontic Department
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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