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.: PACTR201602001477364 Date of Approval: 18/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical Evaluation of a Self-adhering Flowable Composite versus Flowable Composite in Conservative Class I Cavities: Randomized Controlled Trial
Official scientific title Clinical Evaluation of a Self-adhering Flowable Composite versus Flowable Composite in Conservative Class I Cavities: Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Self-adhering flowable composite combines the merits of both adhesive and restorative material technologies (8th generation) in a single product, bringing new horizons and ambitions to restorative procedures, as it is a direct restorative material that contain both adhesive resin together with a flowable composite. With limited evidence based information in literature about using self-adhering flowable composite in conservative class I restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that self adhering flowable composite will have the same clinical performance as flowable composite in conservative class I cavities. The study will use a split mouth design were 20 participants will have 40 restorations (20 per group) in 2 quadrants of the patient mouth.
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 01/06/2016
Actual trial start date
Anticipated date of last follow up 01/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Randomised Simple randomization by using 2 cards in well sealed opaque envelopes (one for the intervention and one for the control) 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 Filtek Z350 XT Flowable (3M ESPE, St. Paul MN, USA) 1 restoration/participant 6 months low viscosity, visible light-cured, radiopaque flowable restorative 20 Active-Treatment of Control Group
Experimental Group Vertise flow (Kerr, Orange, CA, USA) 1 restoration/participant 6 months low viscosity, visible light-cured, radiopaque self-adhering flowable restorative 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria of participants: Patients have small class I carious lesions in their occlusal pits and fissures; Good oral hygiene; Available for follow-up visits. Inclusion Criteria of teeth: Small class I carious lesion in their occlusal pits and fissures; Vital upper or lower posterior teeth with no signs of irreversible pulpitis; One contact at least with an opposing tooth. Exclusion criteria of participants: Patients younger than 19 years old; Known pregnancy; Disabilities; Systemic disease or severe medical complications; Allergic history concerning methacrylates; Rampant caries; Heavy smoking; Xerostomia; Lack of compliance; Evidence of severe bruxism, clenching, or temporomandibular joint disorders. Exclusion criteria of the teeth: Deep carious defects (close to pulp, less than 1 mm distance); Periapical pathology or signs of pulpal pathology; Tooth hypersensitivity; Possible prosthodontic restoration of teeth; Heavy occlusion and occlusal contacts or history of bruxism; Pulpitic, non-vital or endodontically treated teeth; Severe periodontal affection. 19 Year(s) 40 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 02/04/2016 Research Ethics Committee, Faculty of Oral & Dental Medicine Cairo university
Ethics Committee Address
Street address City Postal code Country
11 Saray El Manial st., KASR EL AINY Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative hypersensetivity Baseline (after one week), After 6 months
Primary Outcome Retention analysis Baseline (after one week), After 6 months
Primary Outcome Color match Baseline (after one week), After 6 months
Primary Outcome Marginal discoloration Baseline (after one week), After 6 months
Primary Outcome Marginal adaptation Baseline (after one week), After 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Department, Faculty of Oral & Dental Medicine Cairo University 11 Saray El Manial st., Kasr El Ainy Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None University
COLLABORATORS
Name Street address City Postal code Country
Omar Shaalan 11 Saraya El Manial street, Kasr El Einy Cairo 11553 Egypt
Amira El Zoghby 11 Saraya El Manial street, Kasr El Einy Cairo 11553 Egypt
Eman Abou-Auf 11 Saraya El Manial street, Kasr El Einy Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Shaalan omar.shaalan@dentistry.cu.edu.eg +201122665661 35 Mohamad Farid Street El Hay El Motmayz
City Postal code Country Position/Affiliation
Sixth of October City 12568 Egypt Demonstrator
Role Name Email Phone Street address
Public Enquiries Omar Shaalan omar.shaalan@dentistry.cu.edu.eg +201122665661 35 Mohamad Farid Street El Hay El Motmayz
City Postal code Country Position/Affiliation
Sixth of October City 12568 Egypt Demonstrator
Role Name Email Phone Street address
Scientific Enquiries Omar Shaalan omar.shaalan@dentistry.cu.edu.eg +201122665661 35 Mohamad Farid Street El Hay El Motmayz
City Postal code Country Position/Affiliation
Sixth of October City 12568 Egypt Demonstrator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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