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.: PACTR202307573531455 Date of Approval: 24/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical, Radiographic and Biochemical Assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques. One Year Randomized Clinical Trial
Official scientific title Clinical, Radiographic and Biochemical Assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques. One Year Randomized Clinical Trial
Brief summary describing the background and objectives of the trial One Year Randomized Trial for Clinical, Radiographic and Biochemical Assessment of proximal cavities restored with composite resin using incremental vs. bulk packing techniques. Clinical assessment of caries recurrence using FDI criteria Clinical periodontal assessment using 1.gingival index 2. plaque index 3.papillary bleeding scoring index 4.Periodontal pocket depth Radiographic assessment using Digital bitewing Radiography Biochemical assessment using ELISA to detect MMP 9 To investigate how early can we detect recurent caries on the gingival seat of composite restorations and the corellation between the clinical, radigraghic, periodontal and biochemical findings.
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 Early detection /Screening
Anticipated trial start date 01/07/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 01/10/2023
Actual Last follow-up date 01/04/2024
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 54
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Composite resin restorations performed using bulkfill technique The prepared cavities will be restored with bulk-fill resin composite in one increment at baseline, after 3, 6 months and 12 months. The prepared cavities will be restored with bulk-fill resin composite in one increment 27
Control Group Composite resin restorations performed using conventional incremental packing technique baseline, after 3, 6 months and 12 months one year The prepared cavities will be restored with bulk-fill resin composite in two increments 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
posterior carious molars anterior carious teeth Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 05/01/2022 Research Ethics Committee at the Faculty of Dentistry
Ethics Committee Address
Street address City Postal code Country
October 6 University Faculty of Dentistry, Conservative Dentistry, October 6 city 6th of October City, , EG Giza 12563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical assessment of caries recurrence Baseline, after 3, 6 months and 12 months.
Secondary Outcome Radiographic assessment Baseline, after 3, 6 months and 12 months.
Secondary Outcome Clinical periodontal assessment Baseline, after 3, 6 months and 12 months.
Secondary Outcome Biochemical assessment Baseline, after 3, 6 months and 12 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
October 6 University Faculty of Dentistry October 6 city Giza 12563 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Giza Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marwa Temirek Giza Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Temirek marwa.dent@o6u.edu.eg 01006818314 Giza
City Postal code Country Position/Affiliation
Giza Egypt Associate Professor
Role Name Email Phone Street address
Public Enquiries Monaliza Maher Monalizamaher.dent@o6u.edu.eg 01001400248 Giza
City Postal code Country Position/Affiliation
Giza Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Wessam Shehab 153524@o6u.edu.eg 010092148838 Giza
City Postal code Country Position/Affiliation
Giza Egypt Lecturer
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 at marwa.dent@o6u.edu.eg and will be sent by email to the requesting part. Data sharing will be anonymous to protect participants privacy. Available data include study protocol, raw data and statistical methods Study Protocol After the end of one year follow up Requests for any data should be directed to add marwa.dent@o6u.edu.eg and shall not be limited to specific institutes or 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