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.: PACTR202001541490698 Date of Approval: 13/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical Evaluation of Incremental and Bulk-Fill Composite Restorative Techniques in Enlarged Posterior Occlusal and Proximal Carious Cavities in Nigerian Adults
Official scientific title Clinical Evaluation of Incremental and Bulk-Fill Composite Restorative Techniques in Enlarged Posterior Occlusal and Proximal Carious Cavities in Nigerian Adults
Brief summary describing the background and objectives of the trial BACKGROUND:This study seeks to compare a newer technique to a conventional technique when composite resin is placed on enlarged occlusal and proximal posteior carious cavities in an adult Nigerian population, thus, adding to the body of knowledge regarding placement of composite restorations using two different techniques and more importantly to provide research findings that will be relevant to Nigerian patients care. The study will be a randomized double blind controlled clinical study comparing the clinical performance of incremental and bulk-fill composite placement techniques on enlarged posterior occlusal and proximal carious cavities in Nigerian adults. OBJECTIVE: to evaluate and compare the conventional composite placement with the bulk-fill composite placement technique.
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 05/01/2020
Actual trial start date 05/01/2020
Anticipated date of last follow up 04/01/2022
Actual Last follow-up date 02/01/2022
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 74
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 bulk fill composite placement technique single visit bulk placement Enamel would be selectively etched with 3M Scotchbond™ Universal Etchant (3M ESPE) for 15 seconds, rinsed thoroughly and lightly air-dried as instructed by the manufacturer, 3M Scotchbond™ Universal Adhesive will be applied on both enamel and dentin in 2 consecutive coats, by scrubbing it in with an applicator tip (Henry Schein®), for 20 seconds, followed by gentle air-drying for 2-5 seconds148. It would then be light-cured for 10 seconds using a LED Curing light (Woodpecker®). In the cavity selected for the bulk-fill placement technique, the selected shade of Filtek™ One Bulk Fill Restorative (3M ESPE) would be placed directly into the cavity in a single increment of up to 5mm, and then light-cured for 40 seconds occlusally for occlusal cavities. In proximal cavities, following bulk placement, 20 seconds of light-curing would be done from 3 surfaces-occlusal, buccal and lingual respectively. Occlusal anatomy would be reconstructed before curing. 37
Control Group incremental composite placement technique single visit, incremental placement Enamel would be selectively etched with 3M Scotchbond™ Universal Etchant (3M ESPE) for 15 seconds, rinsed thoroughly and lightly air-dried as instructed by the manufacturer, 3M Scotchbond™ Universal Adhesive will be applied on both enamel and dentin in 2 consecutive coats, by scrubbing it in with an applicator tip (Henry Schein®), for 20 seconds, followed by gentle air-drying for 2-5 seconds. It would then be light-cured for 10 seconds using a LED Curing light (Woodpecker®). In the cavity selected for the incremental placement technique, the selected shade of Filtek™ Z250 Universal Restorative (3M ESPE) would be placed into the cavity in increments of less than 2.5mm, and each increment cured for 20 seconds. Occlusal anatomy would be reconstructed before the final curing 37 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects aged 18 years and above. Subjects with at least 2 clinically detectable occlusal or 2 clinically detectable proximal cavities involving any posterior permanent teeth. Enlarged sized cavities as described in the Mount’s classification. Carious teeth with radiographic evidence of no periodontal or pulpal involvement. Carious teeth should be devoid of pain suggestive of irreversible pulpitis. Subjects who give verbal and signed consent to take part in the study. Subjects with tooth wear. Subjects with parafunctional habits. Subjects with carious teeth lacking opposing and/or abutting standing teeth. Subjects with poor oral hygiene score of greater than 3.0 according to Greene and Vermillion. Fractured or cracked tooth 3rd molars Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 15/03/2019 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107, 1st Floor, LUTH Administrative Block, Idi-Araba. Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The following properties of restoration / intervention would be assessed: Functional properties: • Fracture of material/retention. • Marginal adaptation. • Approximal anatomic form- contact point. Biological properties: • Post-operative hypersensitivity. • Caries recurrence. 12 months.
Secondary Outcome The following properties would be assessed: Functional properties: • Fracture of material/retention. • Marginal adaptation. • Approximal anatomic form- contact point. Biological properties: • Post-operative hypersensitivity. • Caries recurrence . baseline, 3 months, 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Road, Idi-Araba, Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Judith Jolayemi 18/20 Lola Ayocdele Close, off Seliat Bus Stop, Egbeda Lagos 100276 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Restorative Dentistry Lagos University Teaching Hospital Ishaga Road, Idi-Araba Lagos 100254 Nigeria Hospital
Secondary Sponsor Judith Oluwasheun Jolayemi 18/20 Lola Ayodele Close, off Seliat Bus Stop, Egbeda Lagos 100276 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Olabisi Hajarat Oderinu Department of Restorative Dentistry Lagos University Teaching Hospital Lagos 100254 Nigeria
Ilemobade Cyril Adegbulugbe Department of Restorative Dentistry Lagos University Teaching Hospital Lagos 100254 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Judith Jolayemi jolayemijudith@yahoo.com +2348182494887 18/20 Lola Ayodele Close, Off Seliat Bus Stop, Egbeda
City Postal code Country Position/Affiliation
Lagos 100276 Nigeria Senior Resident Lagos University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Judith Jolayemi jolayemijudith@yahoo.com +2348182494887 18/20, Lola Ayodele Close, off Seliat Bus Stop, Egbeda
City Postal code Country Position/Affiliation
Lagos 100276 Nigeria Senior Resident Lagos University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Olabisi Oderinu bisioderinu@yahoo.co.uk +2348023077654 Department of Restorative Dentistry Lagos University Teaching Hospital
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Honorary Consultant Lagos University Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD to be shared include participant biodata- age and gender, tooth cavity type, composite restoration technique used, and clinical assessment at baseline, 3 months, 6 months and 12 months. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years access would be open. data analysis made available include descriptive statistics of mean and standard deviation, frequency and graphs.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/08/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information