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.: PACTR201603001396248 Date of Approval: 19/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical Assessment of Deep Carious Lesions after Partial Removal of Caries vs Stepwise Excavation: A Randomized Controlled Trial
Official scientific title Clinical Assessment of Deep Carious Lesions after Partial Removal of Caries vs Stepwise Excavation: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The traditional method of complete caries removal in vital asymptomatic teeth with deep carious lesions may end in an unnecessary exposure of the pulp. Stepwise excavation is a ¿more conservative¿ approach, but had the drawback of extended treatment time and increased treatment costs. Recently, the need for reentry is questioned and the ¿partial caries removal¿ technique is gaining popularity. Aim of the study: to compare partial caries removal technique to stepwise excavation technique to maintain pulp vitality in permanent teeth with deep carious lesions.
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: Surgery
Anticipated trial start date 20/12/2015
Actual trial start date 03/01/2016
Anticipated date of last follow up 01/04/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
MIU-IRB-1415-002 Misr International University-IRB Chair
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 Block Randomisation (block size 33) 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 Partial Caries Removal Not applicable Not applicable Partial removal of carious dentine with no re-entry to remove remaining caries later 66 Active-Treatment of Control Group
Experimental Group Stepwise Excavation Not applicable Not applicable Partial removal of carious dentine with no re-entry to remove remaining caries later 66 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient-related criteria: ¿Patients consulting in one of the outpatient dental clinic complex, Misr International University. ¿Able to tolerate necessary restorative procedures. ¿Provide informed consent. ¿Accepts one year follow-up period. Tooth related criteria: ¿Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber. ¿Teeth are vital according to pulp-sensitivity tests. Patient-related criteria: ¿Medically compromised patients, as they will not be able to attend multiple appointments or may require special management. ¿Pregnant women; as radiographs cannot be taken for them. ¿Allergy to any of the restorative materials, including anesthetics. ¿Uncooperative patients, will not abide by the instructions or attend the appointments. Tooth related criteria: ¿Deciduous teeth; as the study is targeting only permanent teeth. ¿Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries). ¿Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage. ¿Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis. ¿Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study. ¿Teeth with cervical caries; which can¿t be evaluated on periapical radiographs. 18 Year(s) 50 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 11/10/2015 MIU-IRB Chair
Ethics Committee Address
Street address City Postal code Country
KM 28 Cairo ¿ Ismailia Road Ahmed Orabi District, Cairo ¿ Egypt Cairo 1 Heliopolis Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Maintaining pulp vitality 3 months after 2nd visit 6 months after 2nd visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic complex, Misr International University KM 28 Cairo ¿ Ismailia Road Ahmed Orabi District, Cairo ¿ Egypt Cairo 1 Heliopolis Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Misr International University KM 28 Cairo ¿ Ismailia Road Ahmed Orabi District, Cairo ¿ Egypt Cairo 1 Heliopolis Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Oral and Dental Medicine - Cairo University 11 El-Saraya St. - Manial - Cairo Cairo 11553 Egypt University
Secondary Sponsor Misr International University KM 28 Cairo ¿ Ismailia Road Ahmed Orabi District, Cairo ¿ Egypt Cairo 1 Heliopolis Egypt University
COLLABORATORS
Name Street address City Postal code Country
Division of Operative Dentistry- Department of Restorative Dentistry- Misr International University KM 28 Cairo ¿ Ismailia Road Ahmed Orabi District, Cairo ¿ Egypt Cairo 1 Heliopolis Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Labib mohamed.essam@miuegypt.edu.eg +(20)1009990550 Km28 Cairo-Ismailia Road, Ahmed Orabi District, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 1 Heliopolis Egypt Principal investigator and the one responsible for conducting the trial
Role Name Email Phone Street address
Public Enquiries Amira Kamal Amira.Kamal@miuegypt.edu.eg +201004055837 Km28 Cairo-Ismailia Road, Ahmed Orabi District, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 1 Heliopolis Egypt Secretary for the Ethical Committee
Role Name Email Phone Street address
Scientific Enquiries Mohamed Labib mohamed.essam@miuegypt.edu.eg +201009990550 Km28 Cairo-Ismailia Road, Ahmed Orabi District, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 1 Heliopolis Egypt Responsible for any inquiries regarding the scientific content or background for the trial
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