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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506793306194 Date of Registration: 06/06/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Zinc Oxide Ozonated Oil Versus Modified Triple Antibiotic Paste as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Official scientific title Effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars
Brief summary describing the background and objectives of the trial Preservation of primary dentition is crucial for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss, especially of the primary second molar, can cause several problems. The first permanent molars typically erupt mesially as a result, leading to some problems including the ectopic eruption of the second premolar, the loss of space for the succeeding permanent teeth and functional impairment. In the 1990s, an innovative procedure called lesion sterilization and tissue repair (LSTR) was proposed as an alternative biologic approach that was thought to facilitate the disinfection of dentinal carious lesions, pulp, and periapical lesions in primary teeth with the advantages of being simpler and faster. The LSTR is a minimally invasive endodontic therapy method that involves the introduction of an antibiotic combination in a propylene glycol vehicle to disinfect root canal systems and periapical lesions New generations of disinfecting agents have been developed among them is ozone, which is a powerful oxidizing agent and can be used to eliminate bacteria in root canals. This study aims to evaluate and compare the clinical and radiographic effects of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary 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 01/11/2023
Actual trial start date 01/01/2024
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Zinc Oxide Ozonated Olive oil Zinc oxide powder and ozonated olive oil with a powder-liquid proportion of 4:1 Once Access to the pulp chamber will be gained with a sterile round bur no.330 with water spray to remove all the caries. A sterile Spoon excavator will be used to remove the bulk of the pulp or necrotic debris from the pulp chamber. The canal’s orifices will be enlarged using a round bur to form a medication cavity. That will be prepared at the root canal orificepulp stamps will be dressed by (ZnO-OO) 30
Control Group Modified Triple Antibiotic Paste MTAP paste Ornidazole tablets 500 mg, Ciprofloxacin tablets 500 mg, and Cefaclor tablets 250 mg Once Access to the pulp chamber will be gained with a sterile round bur no.330 with water spray to remove all the caries. A sterile Spoon excavator will be used to remove the bulk of the pulp or necrotic debris from the pulp chamber. The canal’s orifices will be enlarged using a round bur to form a medication cavity. That will be prepared at the root canal orificethe pulp stamps will be dressed by MTAP. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Cooperative patients in the age group of (4-7) years with no associated systemic illness. - Bilateral mandibular primary molars showing signs and symptoms of pulp necrosis or chronic pulp infection with/without hemorrhage, suppuration or purulence. - Spontaneous pain or tenderness to percussion. - Presence of chronic apical abscess or sinus tract or grade I mobility. -The tooth should be restorable. - Radiographic Widening of Periodontal ligament space. - Radiographic Radicular involvement. - Radiographic Furcation involvement less than or equal to half of the shortest root in the vertical dimension Physiologic root resorption more than one third of its length. Excessive internal resorption. Non restorable teeth exhibiting greater than grade I mobility. Perforation into the bifurcation. Any underlying pathological lesion. Any previous history of allergy to the antibiotics used in the study. 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 10/10/2023 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 Pain Althrough period of follow up 12 months
Primary Outcome Fistulous tract Althrough period of follow up 12 months
Secondary Outcome Bone density 12 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of the Department of Pediatric Denistry Faculty of Dentistry Tanta University El Gash street Medical Campus Tanta 31773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nouran esmail Mohamed shalaby El hamoul Menouf 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
Shaimaa Shabaan ElDesokey Elbahr street ,tanta university, pediatric dentistry department Tanta 31773 Egypt
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
Nouran esmail Mohamed shalaby El hamoul Menouf 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.eg 00201225146945 El Gash street Medical Campus
City Postal code Country Position/Affiliation
Tanta 31773 Egypt Assistant Professor 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. 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 06/06/2025 PACTR Admin effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars Effect of zinc oxide-ozonated olive oil (ZnO-OO) versus Modified Triple Antibiotic Paste (MTAP) as a Lesion Sterilization and Tissue Repair Technique in Primary Molars