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.: PACTR201609001768135 Date of Approval: 06/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Using Light Amplified High Intensity Versus Low Intensity LEDs Curing on the Clinical Behavior and Marginal Sealing Of Direct Compound Poste
Official scientific title Effect of Using Light Amplified High Intensity Versus Low Intensity LEDs Curing on the Clinical Behavior and Marginal Sealing Of Direct Compound Posterior Bulk-Fill Resin Composite Restorations: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial The use of light-cured resin composite is increasing as a result of growing demand for esthetic restorations. The greatest limitation in the use of resin composite as a posterior restorative material seems to be shrinkage during polymerization which may lead to microleakage. Microleakage is characterized by the invasion of acids, enzymes, ions, bacteria and bacterial products into the margins of the restoration, causing post-operative sensitivity, recurrent caries, inflammation or even pulp necrosis. (Karthick et al. 2011 and Chandurkar et al. 2014). The impact of the sufficient intensity output of curing lights in ensuring the longevity of restorations and avoiding undesirable clinical outcomes is universally accepted. Light-emitting diode (LED) lights have attracted interest and are becoming increasingly popular among dentists. The early generations of LED lights were not capable of providing adequate output (e.g., 350 mW/ cm2). Newer generation LED lights produce output in excess of 500 mW/cm2. These LED lights provide more consistent outputs than the first-generation units. Most of the studies on resin composite curing stress the importance of sufficient output intensity of curing lights. Undesirable clinical performance and early failures of composite restorations as a result of inadequate polymerization have been reported. Light-emitting diode (LED) lights have attracted interest and are becoming increasingly popular among dentists in comparison to laser and PAC lights. The purpose of this trial is answer a clinical question whether the use of light amplified high intensity (LAHI) LED curing for light curing, when compared to low intensity LED curing, improve the marginal seal and clinical behavior of direct compound posterior bulk-fill resin composite restorations?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Dental caries,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2016
Actual trial start date
Anticipated date of last follow up 30/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status 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 randomisation using a radomisation 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
Experimental Group Dr¿s light AT CL-AT24 light curing system (Good Doctors Co., Ltd., Korea) the restorations will be cured for 5 seconds using the high mode in Dr¿s light AT CL-AT24 light curing light amplified high intensity (LAHI) LED curing for light curing 22
Control Group Dr¿s light AT CL-AT24 light curing system (Good Doctors Co., Ltd., Korea) the restorations will be cured for 20 seconds using the low mode in Dr¿s light AT CL-AT24 light curing low intensity LED curing 22 Active-Treatment of Control Group
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 3mm 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. 12 Year(s) 90 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 27/07/2015 Cairo University - Faculty of Oral and Dental Medicine - Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
12 Saray El Manial st. KASR EL AINY Cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical evaluation of restorations At baseline After 6 months After12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral & Dental Medicine - Cairo University 12 Saray El Manial st. KASR EL AINY Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Oral & Dental Medicine - Cairo University 12 Saray El Manial st. KASR EL AINY Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral & Dental Medicine - Cairo University 12 Saray El Manial st. KASR EL AINY Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelwahed 6th district- 109 buildings quarter - Bulding no. 14- Apartment no. 13 6th October City Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shereen Fahim sherenesameldien@gmail.com +202 01001816565 5 Presidency¿s Artillery Buildings, Elnozha St, Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt
Role Name Email Phone Street address
Public Enquiries Heba Taher heba.taher@dentistry.cu.edu.eg +20201001405763 Faculty of Oral & Dental Medicine - Cairo University.12 Saray El Manial st. KASR EL AINY
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at Conservative dentistry department
Role Name Email Phone Street address
Scientific Enquiries Mohsen Abi-Elhassan mohsen.abielhassan@dentistry.cu.edu.eg +20201003805500 Faculty of Oral & Dental Medicine - Cairo University.12 Saray El Manial st. KASR EL AINY
City Postal code Country Position/Affiliation
Cairo Egypt
REPORTING
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