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.: PACTR202308672010618 Date of Approval: 28/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical evaluation of a universal adhesive in total-etch and selective-etch modes in the restoration of non-carious cervical lesions in Nigerian adults
Official scientific title Clinical evaluation of a universal adhesive in total-etch and selective-etch modes in the restoration of non-carious cervical lesions in Nigerian adults
Brief summary describing the background and objectives of the trial Non-carious cervical lesions are among the most frequent pathologies that affect dental structures. These lesions are used as a clinical model to evaluate the efficacy of dentin-bonding agents in tooth restorations, as recommended by the American Dental Association. Dentin and enamel substrates are different with respect to their composition, requiring different bonding protocols. The study aimed to determine the clinical performance of a universal adhesive in total-etch and selective-etch modes in the restoration of non-carious cervical lesions in an adult Nigerian population.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Non-carious cervical lesions of the teeth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 13/09/2020
Actual trial start date 17/09/2020
Anticipated date of last follow up 09/01/2022
Actual Last follow-up date 25/01/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Total etch mode Application of the restoration just at the first visit The restorations took about 15-20 minutes. The non-carious cervical lesions were restored using universal adhesives in total-etch 30 Active-Treatment of Control Group
Experimental Group Selective etch mode Application of the restoration just at the first visit The restorations took about 15-20 minutes The non-carious cervical lesions were restored using universal adhesives in selective-etch 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects aged 18 years and above Subjects who were available for follow-up visits Subjects with two non-carious cervical lesions of between 1mm and 3mm depth Lesions beyond the enamel extending to dentin. Subjects with rampant uncontrolled caries. Subjects with advanced untreated periodontal diseases. Tooth with periapical pathology. Non-vital tooth or previous root canal therapy. Evidence of severe bruxism, clenching and temporomandibular disorder. 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 14/11/2019 Health Research And Ethics committee of the Lagos State University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
1-5, Oba Akinjobi street, Ikeja Lagos 100271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total-etch and selective-etch groups of universal adhesive showed acceptable clinical performance in aesthetic properties, functional properties, and biological effects in the restoration of non-carious cervical lesions throughout the evaluation period. Baseline, 3-month, 6-month, 12-month
Secondary Outcome The use of universal adhesives for composite restoration performed excellently in both modes of placement in this study. Baseline, 3-month, 6-month, 12-month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos state University Teaching Hospital Dental Centre, 1-5, Akinjobi street, Ikeja Lagos 100271 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Temitope Omosebi No 1-5, Oba Akinjobi Street, GRA, Ikeja Lagos 100271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Temitope Omosebi 1-5, Oba Akinjobi Street, GRA, Ikeja Lagos 100271 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Temitope Omosebi topeisokay@yahoo.com +2348035789221 1-5, Oba Akinjobi Street, GRA, Ikeja
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Consultant
Role Name Email Phone Street address
Public Enquiries Adenike Awotile nikawo2008@yahoo.com +2348033256281 1-5, Oba Akinjobi street, GRA, IKeja
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Cyril Adegbulugbe cyadegbulugbe@hotmail.com +2348033212085 Lagos University Teaching Hospital, Idi Araba
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Anyone who wishes to access the data
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