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.: PACTR201906600044618 Date of Approval: 12/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ONE-YEAR CLINICAL AND RADIOLOGIC OUTCOME OF A BIOACTIVE IONIC RESIN VERSUS NANO-HYBRID COMPOSITE RESTORATION ON CARIOUS POSTERIOR TEETH.
Official scientific title ONE-YEAR CLINICAL AND RADIOLOGIC OUTCOME OF A BIOACTIVE IONIC RESIN VERSUS NANO-HYBRID COMPOSITE RESTORATION ON CARIOUS POSTERIOR TEETH.
Brief summary describing the background and objectives of the trial BACKGROUND: Bioactive restorative materials are a fairly modern innovation in dentistry with a prospect of preventing recurrent caries. One of the few restorative material available is ACTIVA™ BioACTIVE restorative, which acts by; stimulate the natural remineralization process that helps protect teeth against caries, release and recharge essential minerals such as calcium, phosphate, and fluoride and generating a layer of apatite-like substance in the presence of calcium, phospahate and saliva which seals margins against leakage. The introduction of these materials has contributed in revolutionising the management of dental caries through minimal invasive procedures. OBJECTIVE: To evaluate and compare the clinical and radiologic outcome of a bioactive ionic resin and a nano-hybrid composite restoration on carious posterior teeth.
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 02/09/2019
Actual trial start date
Anticipated date of last follow up 01/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants)
Recruitment status Active, not 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
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 ACTIVA BioACTIVE Restorative ONE-YEAR A bioactive restorative material is a bioactive composite with an ionic resin matrix, a shock-absorbing resin component and bioactive fillers similar to the physical and chemical properties of natural teeth. 41
Control Group FILTEK SUPREME ULTRA RESTORATIVE ONE- YEAR Nano-hybrid composite material using nanotechnology 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subjects with at least 2 clinically detectable proximo-occlusal or proximal cavities involving any posterior permanent teeth, with each tooth in the same arch or opposing arch. 2. Moderate cavities according to the International Caries Classification & Management System (ICCMS)333 after plaque removal for an appropriate visual examination of the tooth surfaces by means of prophylactic paste and brush, with appropriate light and the use of a ball-end probe (WHO probe) according to ICDAS examination protocol.69 3. Carious teeth with radiographic evidence of no periodontal or pulpal involvement. 4. Carious teeth should be devoid of pain suggestive of irreversible pulpitis. 5. Subjects who give verbal and signed consent to take part in the study. i. Subjects with tooth wear. ii. Subjects with parafunctional habits. iii. Subjects with carious teeth lacking opposing and/or abutting standing teeth. iv. Subjects with poor oral hygiene score of greater than 3.0 according to Greene and Vermillion.335 v. Fractured or cracked tooth 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) 70 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 06/06/2019 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 SURULERE 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Comparing the clinical and radiological outcome of a bioactive ionic resin with a nano-hybrid composite restoration. Immediately after treatment, 3Months, 6Months and 12Months
Secondary Outcome 1. To determine one-year radiological outcome of ACTIVA™ BioACTIVE restorative material. 2. To determine the level of surface and marginal staining of ACTIVA™ BioACTIVE restorative material at 12-months after restoration 3. To determine the marginal adaptation of ACTIVA™ BioACTIVE restorative material at 12-months after the restoration. 4. To determine the one-year survival rate of ACTIVA™ BioACTIVE restorative material. Immediately after treatment, 3Months, 6Months and 12Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Conservative Dentistry Clinic Lagos University Teaching Hospital DENTA CENTRE, LAGOS UNIVERSITY TEACHING HOSPITAL IDI ARABA SURULERE 12003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OBEHI MARY IKEM LEKKI GARDENS PHASE 2 ESTATE AJAH Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor IKEM OBEHI MARY LEKKI GARDENS PHASE 2 ESTATE AJAH Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
DR UMESI DC DEPARTMENT OF RESTORATIVE DENTISTRY, COLLEGE OF MEDICINE UNIVERSITY OF LAGOS IDI ARABA SURULERE Nigeria
DR AJAYI YO DEPARTMENT OF RESTORATIVE DENTISTRY, COLLEGE OF MEDICINE UNIVERSITY OF LAGOS IDI ARABA SURULERE Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OBEHI IKEM obehi.ikem@gmail.com +2348166804118 LEKKI GARDENS PHASE 2 ESTATE
City Postal code Country Position/Affiliation
AJAH Nigeria SENIOR RESIDENT
Role Name Email Phone Street address
Public Enquiries OBEHI IKEM obehi.ikem@gmail.com +2348166804118 LEKKI GARDENS PHASE 2 ESTATE
City Postal code Country Position/Affiliation
AJAH Nigeria SENIOR RESIDENT
Role Name Email Phone Street address
Scientific Enquiries OBEHI IKEM obehi.ikem@gmail.com +2348166804118 LEKKI GARDENS PHASE 2 ESTATE
City Postal code Country Position/Affiliation
AJAH Nigeria SENIOR RESIDENT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes 1. Participants' age and sex 2. Tooth restored (FDI notation) with which intervention and control restorative material used on tooth 3. Cavity type 4. Cinical and Radiologic parameters at baseline, 3months, 6months and 12months Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Start: 1st May 2021 End: 30th April 2022 Duration: (one-year) Open access Data analysis permitted: Meta analysis Decision (third-party) Qualification: Post doctoral fellow
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