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.: PACTR202109664816731 Date of Approval: 29/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical Evaluation of Flowable versus Packable Bioactive Bulk-Fill Restorative Materials: A Two-Year Randomized Clinical Trial
Official scientific title Clinical Evaluation of Flowable versus Packable Bioactive Bulk-Fill Restorative Materials: A Two-Year Randomized Clinical Trial
Brief summary describing the background and objectives of the trial To compare the clinical performance of flowable bulk versus packable bioactive bulk fill resin composite restorative material In patients with compound proximal cavities in posterior teeth over two years follow-up period.
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: Other
Anticipated trial start date 02/05/2021
Actual trial start date 09/05/2021
Anticipated date of last follow up 05/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 188
Actual target sample size (number of participants)
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group 2 The restoration will be placed immediately after completion of cavity preparation Packable bioactive bulk-fill resin composite restorative material (BEAUTIFUL-Bulk Restorative) 94 Active-Treatment of Control Group
Experimental Group Group 1 The restoration will be placed immediately after completion of cavity preparation Flowable bioactive bulk-fill resin composite restorative material (Beautiful Flow Plus® X) 94
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Clinically diagnosed as moderate-or-deep compound class II cavities; no caries detected on other surfaces. 2- Cavities 4mm or more in depth. 3- No signs and symptoms of pulpal and periapical diseases. 4- An opposing or neighboring tooth to the tooth to be restored exists. 1- Clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure. 2- Poor oral hygiene. 3- Periodontal problems. 4- Heavy bruxism habits. 5- Patients with history of allergic reactions to resin materials or any components of the used materials. 6- Pregnant females. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 05/04/2021 RECO6U
Ethics Committee Address
Street address City Postal code Country
Central Axis Part 1/1 6th October 12585 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Marginal adaptation Baseline, after 6, 12, 18 and 24 months
Secondary Outcome Marginal discoloration Baseline, after 6, 12, 18 and 24 months
Secondary Outcome Postoperative sensitivity Baseline, after 6, 12, 18 and 24 months
Secondary Outcome Retention of restoration Baseline, after 6, 12, 18 and 24 months
Secondary Outcome Recurrence of caries Baseline, after 6, 12, 18 and 24 months
Secondary Outcome Surface roughness Baseline, after 6, 12, 18 and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Department Faculty of Dentistry October 6 University Central Axis - Part 1/1 6th October 12585 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Gamal Abdelwahed Central axis - Part 1/1 6th October 12585 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Gamal Abdelwahed Central axis - Part 1/1 6th October 12585 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Shereen Essameldein Fahim Cental axis - Part 1/1 6th October 12585 Egypt
Monaliza Maher Abdelaziz Cental axis - Part 1/1 6th October 12585 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelwahed 152704@o6u.edu.eg +21223710009 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
Role Name Email Phone Street address
Public Enquiries Sherren Fahim shereenessam.dent@o6u.edu.eg +21001816565 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
Role Name Email Phone Street address
Scientific Enquiries Monaliza Abdelaziz monalizamaher.dent@o6u.edu.eg +21001400248 Central axis - Part 1/1
City Postal code Country Position/Affiliation
6th October 12585 Egypt Lecturer of Conservative Dentistry
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Any data will be available upon request. Requests should be directed to 152704@o6u.edu.eg and will be sent by email to the requesting party. Data sharing will by anonymous to protect participants' privacy. Available data include informed consent form, raw data and statistical methods. Informed Consent Form After the end of 2-year follow up Requests for any data should be directed to 152704@o6u.edu.eg and shall not be limited to specific institutes/researchers
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