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.: PACTR202309545839091 Date of Approval: 01/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative evaluation of the efficiency of visual tactile method, caries detector dye and fluorescence device in diagnosing residual caries after cavity preparation”.
Official scientific title A Comparative evaluation of the efficiency of visual tactile method, caries detector dye and fluorescence device in diagnosing residual caries after cavity preparation”.
Brief summary describing the background and objectives of the trial : Dental caries (DC) still remains a common condition among adults with increasing prevalence rates in low-income countries. In its treatment, deep carious lesions may pose the challenge of balancing adequate caries removal to prevent residual caries and excessive sound dentine removal. The extent of carious dentine excavation is subjective based on the clinician’s assessment of the color and texture or hardness of the dentine, which is the visual-tactile method. The acceptable amount of infected dentine that can be left behind during cavity preparation remains a debate as there is no definite diagnostic tool available to clinically define the caries-removal limit. The study therefore aimed to compare the efficiency of visual-tactile, caries detector dye (CDD) and laser fluorescence (LF) device methods of residual caries diagnosis after cavity preparation.
Type of trial CCT
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 Diagnosis / Prognosis
Anticipated trial start date 07/08/2022
Actual trial start date 07/08/2022
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Recruiting
Publication URL not yet
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group dental caries excavation with visual and tactile method nil nil Visual and tactile method The cavity will be assessed visually using a dental mirror and the tactile assessment will be done using a probe/explorer to ensure satisfactory residual caries removal. The visual inspection will assess the colour of the prepared cavity floor and walls under a dental unit light for the absence of any discoloration (brown, yellowish brown or black). For tactile assessment, the dentine texture (hard or soft) will be assessed with a probe/explorer (#23 dental explorer, USA CE) by the researcher. Caries removal will be considered as complete when the explorer does not stick to the dentine and there is no tug-back sensation.35,118 Dentine samples will be taken under aseptic condition with a sterile rose head bur mounted on a slow hand piece.119 The dentine flakes generated on the bur will be dispensed on two sterile swab sticks which will be handled by the assistant and which will be re-capped immediately. The sample is then sent to the laboratory and subjected to culture by inoculation on the blood agar (BA) and chocolate agar (CHA) 30 Active-Treatment of Control Group
Experimental Group dental caries excavation followed by caries detector dye nil nil Visual and tactile along with caries detector dye Conventional cavity preparation will be done and the visual and tactile assessment will be carried out as in group A. Then the CDD (CARIOfinder) will be dispensed into a dish and will be applied to the cavity using an applicator brush or cotton pellet. The cavity will be rinsed and air-dried after 1minute of dye application. The CDD evaluation will be converted to numeric scores of 0, when the color of the dentin remained the same and 1 when the color of the dentin stained blue. The location of staining will also be recorded. This area of blue staining will be collected using a rose head bur mounted on a slow hand piece. The dentine flakes generated on the bur will be dispensed on two sterile swab sticks which will be handled by the assistant and which will be re-capped immediately. The sample is then sent to the laboratory and subjected to culture by inoculation on the blood agar (BA) and chocolate agar (CHA). 30
Experimental Group dental caries excavation followed by laser fluorescence device nil nil Visual and tactile along with laser fluorescence Conventional cavity preparation will be done and the visual and tactile assessment will be carried out as in group A. The LF device (DIAGNOdent pen) will first of all be calibrated and this is done holding the tip in air away from direct light and pressing the “menu” button of the device followed by the save button. The device tone will begin and the tip will be gently placed on the calibration disc at 90 degrees holding it steadily.121 The tone stops when the calibration is complete and the digit on the DIAGNOdent display will be the same as the digit on the calibration disc. The cavity will be evaluated using the probe tip. The probe tip will be placed perpendicularly on the cavity and will be slowly moved to examine the adjacent surfaces of the cavity at various angles. The area of maximum fluorescence will be noted and recorded as shown on the DIAGNOdent pen display for presence of residual caries (>15) or absence (<15). Dentine sample from the area of maximum fluorescence will be collected with a sterile bur and dispensed on two sterile swab sticks. The sample will then be sent to the laboratory for inoculation on the BA and CHA and subjected to culture 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All consecutive adult subjects above the age of 18, in good general health, presenting at the oral diagnosis clinic. 2. Adults with at least one permanent molar/ premolar diagnosed to have DC 3. Adults with at least one permanent molar/ premolar diagnosed to have DC, in dentine, without irreversible pulpal damage or periapical involvement and with sufficient extension to allow DIAGNOdent placement within the excavation 1. Carious lesions associated with signs and symptoms of irreversible pulp inflammation and or periapical inflammation. These will also include tooth/teeth with: a. History of spontaneous pain b. History of swelling c. Presence and/or preceding history of discharging sinus d. Tenderness on palpation and/or percussion e. Grossly broken down tooth f. Periradicular or periapical radiolucency. h. Advanced periodontal diseases: grade III mobility i. True negative response to pulp sensibility test j. Coronal radiolucency due to caries that appears to communicate with pulp, with or without symptoms k. Pulpal bleeding (exposure) during caries excavation l. Traumatized teeth m. Third molars 2. Subjects that have been on antibiotics or steroids within a period of three months prior to the study period. 3. Pregnant women. 4. Subjects that decline to consent to the treatment procedure, despite elaborate explanations of the treatment protocols. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 74 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 04/07/2023 RESEARCH AND ETHICS COMMITTEE UMTH
Ethics Committee Address
Street address City Postal code Country
OFF BAMA ROAD MAIDUGURI PMB 1414 Nigeria
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 01/02/2022 RESEARCH AND ETHICS COMMITTEE UMTH
Ethics Committee Address
Street address City Postal code Country
OFF BAMA ROAD MAIDUGURI PMB 1414 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Detection of residual caries , streptococcus mutans in specific After bacterial culture
Secondary Outcome relationship between the three methods of residual caries detection After bacterial culture results
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
MAIDUGURI OFF BAMA ROAD, MAIDUGURI, BORNO STATE MAIDUGURI PMB 1414 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF OFF BAMA ROAD, MAIDUGURI MAIDUGURI PMB1414 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SELF OFF BAMA ROAD, MAIDUGURI MAIDUGURI PMB1414 Nigeria SELF
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator HADIZA ABBA MOHAMMED amhadiza@gmail.com +2349131329255 off bama road , Maiduguri
City Postal code Country Position/Affiliation
MAIDUGURI PMB 1414 Nigeria UNIVERSITY OF MAIDUGURI
Role Name Email Phone Street address
Public Enquiries PAUL IKHODARO IDON idonp85@gmail.com +2348033890578 off bama road , Maiduguri
City Postal code Country Position/Affiliation
MAIDUGURI PMB 1414 Nigeria UNIVERSITY OF MAIDUGURI
Role Name Email Phone Street address
Scientific Enquiries PAUL IKHODARO IDON idonp85@gmail.com +2348033890578 off bama road , Maiduguri
City Postal code Country Position/Affiliation
MAIDUGURI PMB 1414 Nigeria UNIVERSITY OF MAIDUGURI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Immediately following publication, No end date not available
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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