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.: PACTR202307691266403 Date of Approval: 27/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Endocrowns in anterior teeth: Effect of cementation protocols and restorative materials on the clinical performance and longevity of the restorations
Official scientific title Endocrowns in anterior teeth: Effect of cementation protocols and restorative materials on the clinical performance and longevity of the restorations
Brief summary describing the background and objectives of the trial For a long time, rehabilitation of endodontically treated teeth with extensive coronal destruction has been problematic. The poor structural integrity resulting from caries and/or cavity preparation has a detrimental effect on the restorative choice. Posts have been long proposed as the treatment of choice for teeth with insufficient coronal tooth structure to retain a core for the final restoration. Several studies reported that the application of posts cause weakening of the roots, the risk of perforation, and bacterial contamination during root canal preparation. The presence of these risks helped in making endocrown restorations float on the surface as an alternative to the traditional post and core method. This trial aims to assess the performance of anterior endocrown restorations fabricated from zirconia and E-max materials and cemented with different protocols.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/04/2021
Actual trial start date 01/04/2021
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date 01/04/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lithium Disilicate Ceramic material 20 1 year E-Max is a glass ceramic material composed of SiO2. Li2O, K2O, P2O5, ZrO2,ZnO, other oxides, and coloring oxides. It is used for the fabrication of dental crowns and bridges due to its high strength and good esthetics 20
Control Group Zirconia Ceramic material 20 1 year Zirconia restorations are categorized into two main categories: zirconia-based restorations and monolithic zirconia restorations. The monolithic type is presented as full contour zirconia ceramics and it has some advantages over the zirconia-based ones. Monolithic type is to be used in this study 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Participants' ages ranged from 20 to 65 years, and they had to be able to read and sign the consent. 2) Patients had to be fit and willing to come for the follow-up sessions ; 3) Patients who had no medical condition or systemic disease that may affect the treatment; 4) Patients with no active periodontal disease; 5) Patients with upper anterior teeth indicated for endodontic treatment and having t at least 2-3mm of tooth structure above the cement-enamel junction. 1) Patients who are diagnosed with any medical conditions interfering with he treatment 2) Patients who are expressing unrealistic expectations; 3) patients with missing lower anterior teeth 4) patients with parafunctional habits (clenching or bruxism) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 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 10/02/2021 Dental Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
1 ElGeish Road Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome is to measure success of the restoration against the USPH criteria T3 T6 T9 T12
Secondary Outcome Patient satisfaction T3 T6 T9 T12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Dentistry in Mansoura University 1 El Gomhouria St, Dakahlia Governorate Mansoura 35516 Egypt
Faculty of Dentistry in Kafr Elsheikh univerity Mubarak Rd, Kafr Abu Tabl Kafr ElSheikh 33516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nehal Mahmoud Mohamed Samra Tourail Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nehal Mahmoud mohamed Samra Saad Zaghloul, Tourail Mansoura 35511 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nehal Mahmoud Mohamed Samra nehal_samra@hotmail.com +201006789321 Saad Zaghloul street
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Assistant Lecturer in Faculty of Dentistry Kafr ElSheikh University
Role Name Email Phone Street address
Scientific Enquiries Manal Abu Madina profmmadina@gmail.com +201280308033 Gihan Street
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of Fixed Proshodontics in Faculty of Dentistry Mansoura University
Role Name Email Phone Street address
Public Enquiries Lamiaa Dawoud lamiaa_dawoud@yahoo.com +201006290700 Madinat Al salam
City Postal code Country Position/Affiliation
Mansoura Egypt Professor of Fixed Prosthodontics in Faculty of Dentistry Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). The study protocol and statistical analysis will be available 3 months following publication with no end date for anyone who wishes to access the data and for any purpose. Study Protocol 2 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information