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.: PACTR201812884054327 Date of Approval: 10/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical and radiographic evaluation of “Endoflas” versus “Zinc Oxide and Eugenol” as root canal filling material in primary molars: A randomized controlled trial.
Official scientific title Clinical and radiographic evaluation of “Endoflas” versus “Zinc Oxide and Eugenol” as root canal filling material in primary molars: A randomized controlled trial.
Brief summary describing the background and objectives of the trial A dentist who provides emergency or restorative care for children will certainly encounter for a situation where a primary tooth has a pulp exposure The main objective of endodontic treatment is total elimination of micro-organisms from the root canal, and the prevention of subsequent re-infection. However, the complex morphology of the canal system in the deciduous teeth makes it difficult to achieve proper cleansing by mechanical instrumentation and irrigation of the canals . This has led to the search for an effective filling material which could overcome all instrumentation obstacles, leading to success of root canal treatment. To the present time, Zinc oxide Eugenol (ZnOE), iodoform and calcium hydroxide Ca (OH)2 pastes are the most commonly used materials. Zinc oxide Eugenol is one of the most widely used materials for root canal filling in primary teeth. However, animal studies with ZnOE as an obturating material have reported chronic inflammatory reactions and slow resorption. The retained material alters the path of eruption of permanent teeth in 20% of cases. Moreover, it has limited antibacterial efficacy. The addition of iodoform to Ca(OH)2 containing pastes has received attention in the past. In contrast to ZnOE, these materials are known to have some antimicrobial action and undergoes resorption easily. In the recent past a material containing ZnOE, iodoform and (Ca(OH)2) was introduced in South America with the commercial name ‘Endoflas’. It is a material that encompasses the desirable properties of ZnOE, Ca(OH)2 and iodoform. It is hydrophilic, firmly adheres to the surface of the root canal walls, and has an ability to disinfect the dentinal tubules. Despite the numerous advantages that Endoflas has over ZnOE, it is still not the most widely employed material for root canal filling in a primary tooth.The aim of this study was to compare the clinical and radiographic success rates of Endoflas and ZnOE used as root canal filling material in the treatment of vital primary molars indicated for pulpectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Oral Health
Sub-Disease(s) or condition(s) being studied pulpectomy in vital primary molars
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2016
Actual trial start date
Anticipated date of last follow up 01/05/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Completed
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Zinc Oxide Eugenol 9 months Root canal filling material in the treatment of primary molars indicated for pulpectomy 42 Active-Treatment of Control Group
Experimental Group Endoflas 9 months Root canal filling material in the treatment of primary molars indicated for pulpectomy 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Cooperative patients with age range 4-7 years. Vital tooth with carious pulp exposure, diagnosed as having irreversible pulpitis on basis of reported symptoms and/or clinical findings. (eg. profuse hemorrhage following pulpotomy procedure). Restorable tooth. Tooth with at least two-third of intact root length. Informed consent was obtained from each patient. Patients with systemic diseases. Patients refused follow up protocol. Tooth with preshedding and abnormal pathologic mobility. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 7 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 22/07/2015 research ethics committee
Ethics Committee Address
Street address City Postal code Country
11 El Saraya street-Manial cairo 11553 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Presence of pain, swelling, sinus/fistula or mobility 3,6 and 9 months
Secondary Outcome presence of periapical radiolucency,furcation involvement,internal and external root resorption 3,6 and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pediatric Dentistry and Dental Public health Department faculty of Dentistry Cairo university 11 El Saraya street-Manial Cairo 11553 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Main investigator 11 ElSaraya street - Manial Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Pediatric Dentistry and Dental Public Health 11 El Saraya street-Manial Cairo 11553 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Department of Pediatric Dentistry and Dental Public Health Faculty of Dentistry Cairo University 11 El Saraya street- Manial Cairo 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mona Wahby moonwahby@gmail.com +201001651407 11 El Saraya street, Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assistant lecturer in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Mona Wahby moonwahby@gmail.com +201001651407 11 El Saraya street-Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assistant lecturer Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Beni Suef University
Role Name Email Phone Street address
Principal Investigator Mona Wahby moonwahby@gmail.com +201001651407 11 El Saraya street -Manial
City Postal code Country Position/Affiliation
Cairo 11553 Egypt Assistant lecturer Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Beni Suef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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