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.: PACTR201908519911054 Date of Approval: 05/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical performance of Conventional and resin modified glass ionomer cements modified with Nano-hydroxyapatite particles in class V cavities: A Randomized Controlled Clinical Trial
Official scientific title Effect of Nano-hydroxyapatite Incorporation into Conventional and Resin Modified Glass Ionomer Cements on Shear Bond Strength to Sound and Caries-Affected Dentin (An In-vitro / in-vivo study).
Brief summary describing the background and objectives of the trial In spite of all advances and modifications evolved for improvement of the poor mechanical properties associated with glass ionomer restorative materials, a significant improvement has not yet been approached. Previous studies investigated the effect of addition of Nano-HAp to GICs and RMGICs on microhardness, microleakage and remineralization potential of GICs. At the same time there were only few studies providing data about the effect of incorporation of Nano- HAp on the shear bond strengths of GICs and RMGIC to dentin. Moreover; the results of these studies were contradicting and comparison between them may be difficult. This might be referred to variations in research protocols and methodology employed between different researchers. This study will be conducted to evaluate the effect of incorporation of 5 wt% Nano-HAp to conventional glass ionomer and resin modified glass ionomer cements on their clinical performance in class V cavities at different time intervals; baseline, 3, 6 and 9 months.
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 15/08/2019
Actual trial start date
Anticipated date of last follow up 20/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
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 Conventional Glass Ionomer without Nano HAP 9 months Class V cavities for all participants will be prepared just by removal of carious lesions. All cavities will be conditioned with 10% polyacrylic acid, and then irrigated and dried carefully. The glass ionomer cement will be manually mixed according to manufacturer's instructions, and then placed into the prepared cavities. Restorations will be contoured, finished and polished. 15 Active-Treatment of Control Group
Experimental Group Nano HAPGIC 9 months Class V cavities for all participants will be prepared just by removal of carious lesions. All cavities will be conditioned with 10% polyacrylic acid, and then irrigated and dried carefully. The Nano HAP glass ionomer cement will be manually mixed according to manufacturer's instructions, and then placed into the prepared cavities. Restorations will be contoured, finished and polished. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Criteria related to patient: • Age's eligible for trial was 25- 45 years. • Able to read and sign the informed consent form. • Cooperative patients who are willing to participate and able to continue the schedule time of work. • Accepted healthy volunteers.  Criteria related to tooth: • Presence of contra-lateral matched pair of teeth with carious buccal cervical lesion involving the gingival 1/3. • Small to medium size cavities that extended into dentin, while maintain natural tooth contour. • Absences of tooth mobility, extensive carious lesion, sever pain or pre-operative sensitivity. • Tooth that meet A3 color shade selection. • Easily accessible gingival margins during tooth restoration.  Criteria related to patient: • Patients with poor oral hygiene. • Patients with Rampant uncontrolled caries. • Patients with any para functional habit, bruxism or abnormal occlusion. • Patients with compromised medical history. • Pregnant or breast feeding females. • Heavy smoker's patient. • Patient suffering from any condition that could affect salivary flow (e.g., salivary gland disorder, sjögren's syndrome). • Evidence of xerostomia. • Abnormal oral soft tissue finding (oral ulcers, open sores and oral lesions).  Criteria related to tooth: • Teeth with periapical pathology or exhibiting any symptoms of pulp pathology. • Teeth that are doubt about vitality or have root canal therapy. • Teeth have been pulp capped. • Teeth with periodontal pocket and bleeding on probing. • Cracked teeth. • Hypersensitive teeth. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 25 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 24/03/2016 Medical Research Ethics Committee MREC
Ethics Committee Address
Street address City Postal code Country
33 Al Buhouth St., Dokki Cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical Performance USPHS criteria 9 months
Secondary Outcome Survival rate of restoration 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Research Centre 33 el Buhouth st., El Dokki Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Centre 33 El Buhouth st, El Dokki Cairo 12622 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zeinab Mahmoued Zaki 6 Palm City, Kattameya Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Rania Shalaby 3, street 163, Maadi Cairo Egypt
Ahmed Saaed 22, Damascus street, Heliopolis Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeinab Zaki Zeinabzaki7@gmail.com +201224466176 6 Palm City, El Kattameya
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Researcher
Role Name Email Phone Street address
Public Enquiries Shaimaa Nagi snagi@gmail.com +201223961781 34, street 79, 5th settlement
City Postal code Country Position/Affiliation
Cairo Egypt associate professor
Role Name Email Phone Street address
Scientific Enquiries Dina El Kassas dinaelkassas2000@yahoo.com +201221139772 45, 7th district, El Shorouk City
City Postal code Country Position/Affiliation
Cairo Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes It is decided that IPD data will be available for this clinical trial. Data can be shared as study protocol, statistical analysis and results. also informed consent of each patient will be available. All data can be available as soft copies (microsoft word document, excel sheets) provided upon request. Data will be available in a time frame of 12 months from the completion of the study Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months after the completion of the study. Access for improving medical research. Data can be re-analyzed, validated or combined with other data from similar studies.
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