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.: PACTR201609001777364 Date of Approval: 09/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical And Radiographic Evaluation Of Aloe Vera Gel Versus Formocresol Pulpotomy Of Vital Primary Molars: A Randomized Clinical Trial
Official scientific title Clinical And Radiographic Evaluation Of Aloe Vera Gel Versus Formocresol Pulpotomy Of Vital Primary Molars: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial This study will be done to compare between Aloe vera gel and formocresol as a material for pulpotomy in vital primary molars in terms of post operative pain and the prevention of the occurrence of radiolucent lesions at furcation or periapical region.
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: Drugs
Anticipated trial start date 20/12/2016
Actual trial start date
Anticipated date of last follow up 20/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not 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 Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aloe Vera gel once once 21 Active-Treatment of Control Group
Control Group formocresol once once 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Young cooperative patients with no history of systemic disease. 2.Age range 4-5 years. 3.Patients having decayed vital second primary molars indicated for pulpotomy. 4.No clinical symptoms or evidence of pulp degeneration, such as spontaneous pain, pain on percussion, history of swelling, sinus tracts or pathological mobility. 5. Tooth is restorable. 6. Tooth with at least two-third of intact root length. 7. Tooth showing no radiographic signs of pulpal or interradicular involvement ranging from slight thinning of the trabeculae to furcal and/or periapical radiolucency. 1.Patients with systemic diseases. 2. Patients who cannot attend follow up. 3.Tooth with preshedding and abnormal pathologic mobility. 4.Tooth with internal/external root resorption involving permanent tooth follicle. 5. Tooth showing perforation of pulpal floor. 4 Year(s) 5 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
No 10/10/2016 the Ethics Committee of Scientific Research - Faculty of oral and dental medicine ¿ Cairo University.
Ethics Committee Address
Street address City Postal code Country
11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain after 3 months after 6 months after 9 months after 12 months
Secondary Outcome Occurrence of radiolucent lesions at furcation or periapical region after 3 months after 6 months after 9 months after 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Oral and Dental Medicine, Cairo University 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of pediatric dentistry and dental public health faculty of oral and dental medicine, Cairo University 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Sherine Ezz Eldin Taha 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
Prof. Dr. Salah Eldin Mostafa Elbehairy 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
Dr. Randa Youssef Abd EL Gawad 11, el Saraya street , el Manial, Cairo, Egypt. Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shereen Shabaan Mustafa Drshery77@gmail.com 01006961298 11 el Saraya Street, el Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assistant Lecturer Pediatric Dentistry, Faculty Dentistry, Oct Univ of Modern Sciences and Arts
Role Name Email Phone Street address
Public Enquiries Randa Youssef Abd Elgawas Randa.youssef@yahoo.com 01222272010 11 el Saraya Str, el Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assoc Prof Pediatric Dentistry and Dental Public Health, Faculty Oral and Dental Med, Cairo Univ
Role Name Email Phone Street address
Scientific Enquiries Randa Youssef Abd Elgawad Randa.youssef@yahoo.com 01222272010 11 el Saraya Street, el Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assoc Prof Pediatric Dentisry and Dental Public Health, Faculty Oral and Dental Med, Cairo Univ
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