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.: PACTR202402514349175 Date of Approval: 29/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical and Radiological Evaluation of NeoPutty MTA and Activa bioactive base as Indirect Pulp Capping in Immature First Permanent Molars
Official scientific title Clinical and Radiological Evaluation of NeoPutty MTA and Activa bioactive base as Indirect Pulp Capping in Immature First Permanent Molars
Brief summary describing the background and objectives of the trial The foundation stone is the first permanent molars, which play a key role in balanced occlusion,as a result of the early time of eruption ,its more predisposed to caries. So preserving pulp vitality is an important priority in the treatment of deep caries lesions with indirect pulp capping and direct pulp capping . the indirect pulp capping (IPT)starts with removal of the infected dentin, leaving a thin layer of underlying affected ,then cavity sealed with a pulp capping materials and restorative material is placed . In this study we compare and evaluate between two bioactive materials: Activa base and neo putty MTA as indirect pulp capping materials for newly erupted first permanent molars.
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: Drugs
Anticipated trial start date 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 31/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL N/A
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 Permuted block randomization 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 Activa bioactive base Activa bioactive base will be applied according to size of remaining caries Activa bioactive will be applied once Caries will be removed then the Acitiva will be applied and covered by glass ionomer restoration 18
Control Group Neo putty MTA Neo putty MTA will be applied according to size of remaining caries Neo putty MTA will be applied once Caries will be removed then the MTA will be applied and covered by ionomer restoration 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Cooperative Patient - patients with large carious lesions involving either the occlusal or proximal surfaces in immature first permanent molars. - History intermittent pain, mild discomfort associated with eating - Radiological: Carious lesion involving about one third thickness of dentin. - Radiological: No pre apical or pre radicular radiolucency . - Radiological: Normal lamina dura and No evidence of internal or external resorption. - Systemic diseases, such as diabetes, rheumatic disease, and congenital heart disease. - History of sharp pain, necrosis and abscessed teeth, penetrating pulpalgia indicating acute pulpal inflammation. - Clinical examination showing presence of mobility of tooth and discoloration of tooth. Radiographical: Carious tooth with definite pulp exposure, widened periodontal ligament space, periapical radiolucency. Child: 6 Year-12 Year 6 Year(s) 9 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 30/09/2023 Research Ethics Committee Faculty of Dentistry Tanta University
Ethics Committee Address
Street address City Postal code Country
El Gash street Medical Campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Layer of reparative dentine After 9 months of intervention
Secondary Outcome Density of dentin After 9 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Pediatric Dentistry Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Qamar magdy sallam El ftouh school street Elsanta 31631 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Dentistry Department Faculty of Dentistry Tanta University. El Gash street Medical Campus Tanta 31773 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Abd El Moniem El Hendawy Elbahr street ,tanta university, pediatric dentistry department Tanta 31773 Egypt
Nancy Mohammed Metwally Elbahr street ,tanta university, pediatric dentistry department Tanta 31773 Egypt
Qamar magdy sallam El ftouh school street Elsanta 31631 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatma Elhendawy elhendawy4@gmail.com 00201001531593 Elbahr street ,tanta university, pediatric dentistry department
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Professor of Pediatric Dentistry Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Scientific Enquiries Nancy Metwally Nancy.mohamed@dent.tanta.edu.e 00201225146945 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Lecturer of Pediatric Dentistry Faculty of Dentistry Tanta University
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries) All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: Immediately following publication with no end date. For anyone who wishes to access the data For any type (purpose) of analyses Upon proposal(s) that should be directed to elsayedamr@yahoo.com Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to elsayedamr@yahoo.com Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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