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.: PACTR202310536055770 Date of Approval: 25/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized clinical trial of the efficacy of universal and fifth generation adhesives in restored fractured anterior teeth of children aged 8-16years
Official scientific title Randomized clinical trial of the efficacy of universal and fifth generation adhesives in restored fractured anterior teeth of children aged 8-16years
Brief summary describing the background and objectives of the trial Globally, traumatic dental injuries (TDI) are common in children and on the increase. Most times, the treatment of enamel-dentine fractured anterior teeth involves the use of composite resin with the etch-and-rinse adhesive system. However, due to the multiple steps and time taken in etching, rinsing and drying, this system is considered to be easily prone to error. The quest for adhesives systems that are more user-friendly and less technique -sensitive has led to the development of the novel universal adhesive. However, there is a gap in the literature on their use in restoration of fractured anterior teeth. Specific Objectives 1. To evaluate the efficacy of a fifth-generation adhesive system, 3M ESPE Adper Single Bond 2 (St Paul MN USA) in direct composite restoration of enamel-dentine fractured permanent maxillary incisors by assessing the retention, marginal discolouration, marginal adaptation, presence of caries, and postoperative sensitivity of the composite restoration, in children aged 8 to 16years. 2. To evaluate the efficacyof the universal adhesive system, 3M ESPE Scotchbond Single Bond (Neuss Germany) in direct composite restoration of enamel-dentine fractured permanent maxillary incisors by assessing the retention, marginal discolouration, marginal adaptation, presence of caries, and postoperative sensitivity of the composite restoration, in children aged 8 to 16years. 3. To compare the clinical efficacy of the fifth-generation adhesive, 3M ESPE Adper Single Bond 2 (St Paul MN USA) and the universal adhesive, 3M ESPE Scotchbond Single Bond (Neuss Germany) in direct composite restoration of permanent maxillary incisors with enamel-dentine fracture in children aged 8 to 16years.
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: Other
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 01/10/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of Universal adhesive in composite restoration of fractured anterior teeth One tooth restoration for each participant once only. one year observation after restoration Participant with fractured anterior teeth will composite restoration performed with either the fifth generation or universal adhesive(bonding agent) 70
Control Group fifth generation adhesive in restoration of fractured anterior teeth A smear per tooth per tooth restored, once during the treatment one year Fractured anterior with be restored with composite resin using the fifth generation adhesive 70 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria 1. Patient must be between ages 8 and 16 years. 2. Patient must have or be willing to maintain a good oral hygiene. 3. Patient/parent must be willing to participate and the parent or guardian must be willing to sign the informed consent form 4. Patient with enamel-dentine fracture, ICD-11 code NA0D 2, involving the central and or lateral incisors. 5. Tooth must be vital Exclusion criteria 1. Patient with an acute or chronic pulpitis or dentoalveolar abscess. 2. Patient with poor oral hygiene. 3. Patient with systemic illness. 4. Patient on orthodontic appliance therapy. 5. Patient with oral and parafunctional habits such as bruxism. 6. Patient with periodontal disease and mobile teeth. 7. Cases where there is pulpal exposure or dentine is too close to the pulp. 8.Patient with enamel defects 9.Patient with accident-prone profile. 10. Inability to return for recall appointment Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 8 Year(s) 16 Year(s) Male
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 22/03/2023 UPTH Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Choba Port Harcourt Port Harcourt 500102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anticipated outcome is that the universal adhesive may be as effective as the fifth generation in composite restoration of fractured anterior teeth one week, four months, 8months and 12months
Secondary Outcome The possible secondary outcome is that the universal adhesive may be more effective than the fifth generation adhesive one week, four months, 8months, 12months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Port Harcourt Teaching Hospital Choba UPTH Port Harcourt 500102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Raymond Stanley Chukwunonso Choba Port Harcourt Port Harcourt 500102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Raymond Stanley Chukwunonso Choba Port Harcourt Port Harcourt 500102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stanley Raymond raymondstanleychukwu@gmail.com +2348038486067 Choba Port Harcourt
City Postal code Country Position/Affiliation
Port Harcourt 500102 Nigeria Senior Registrar Child Dental Health university of Port Harcourt Teaching Hospital
Role Name Email Phone Street address
Public Enquiries James Olutayo facsecfmcds@npmcn.edu.ng +234080745933 km 26 Lagos Badagry Expressway Ijanikin
City Postal code Country Position/Affiliation
Lagos PMB 2003 Nigeria Faculty Secretary National Postgraduate Medical College of Nigeria
Role Name Email Phone Street address
Scientific Enquiries Abiodun Arigbede arisabbey@gmail.com +2347055736436 Choba Port Harcourt
City Postal code Country Position/Affiliation
Port Harcourt 500102 Nigeria Professor and consultant Prosthodontist University of Port Harcourt Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data(IPD) shall be made available. This will include all the IPD collected during the trial after de identification. Other documents that shall be made available include the study protocol, statistical analysis, plan, informed consent form, clinical study report and analytical code. The data shall be available immediately following publication with no end data and for any purpose at a link to be provided after publication. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within one year of study completion date. Access shall be open Any type of analysis applicable No protocol needed Third Party Any interested reseacher
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Shall be available after publication 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