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.: PACTR202112595280782 Date of Approval: 10/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF ORAL HYGIENE INSTRUCTION MOBILE APPLICATION ON THE ORAL HEALTH OF PATIENTS UNDERGOING FIXED ORTHODONTIC TREATMENT: A RANDOMISED CLINICAL TRIAL
Official scientific title EFFECT OF ORAL HYGIENE INSTRUCTION MOBILE APPLICATION ON THE ORAL HEALTH OF PATIENTS UNDERGOING FIXED ORTHODONTIC TREATMENT: A RANDOMISED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial SUMMARY Maintaining good oral health status during fixed orthodontic treatment is absolutely important, because patients undergoing fixed orthodontic appliances therapy have an increased risk of biofilm accumulation as a result of difficulty in biofilm control. Several interventions to improve oral hygiene compliance such as verbal instructions, written instructions, illustrations using catalogs, videos, telephone calls, text messages, chat groups and oral hygiene mobile application have been reported. The aims of this study are to develop and validate a mobile application and assess the effect on oral hygiene status, gingival health and white spot lesion in patients undergoing fixed appliance therapy. Design: A single-blinded randomized controlled trial with two parallel arms. Setting: The study shall be conducted at the Orthodontic Unit of the Child Dental Health clinic, Obafemi Awolowo University Teaching Hospital Complex, Ile-Ife, Osun State. Methods: A mobile application will be developed called IFEORTHOCARE mobile app that will illustrate oral education using a validated video, remind the patients about their oral health compliance with the aid of a push button alert and empower the patients and clinicians to monitor oral hygiene compliance using a feedback support in form of a graphical display of daily duration of tooth brushing. Forty-six (46) participants undergoing fixed appliances will be randomly assigned to one of two groups consisting of group A (n=22) and group B (n=24) based on simple randomization technique. Group A will receive the app while group B will be given verbal instruction. Three primary outcomes will be assessed using structured questionnaire to validate the usability of the app after 12 weeks of use; Orthodontic Plaque Index (OPI), Gingival Index and White Spot Lesion Index (WSLI) will be used to evaluate the oral hygiene status, gingival health and white spot lesions respectively at baseline, 4 weeks, 8 weeks and 12 weeks. Data collect
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 Prevention
Anticipated trial start date 02/03/2020
Actual trial start date
Anticipated date of last follow up 18/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 46
Recruitment status Recruiting
Publication URL There is non for now
Secondary Ids Issuing authority/Trial register
ERC 2019 10 08 ETHIC AND RESEARCH COMMITTEE, OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITAL COMPLEX
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group The use of mobile apps named IFEORTHOCARE mobile app to improve oral hygiene of patients. It sends reminder notification to patients three times daily. Duration of 12 weeks. The app was conceptualized to overcome the problem of poor oral hygiene associated with patients undergoing fixed appliance therapy. The concept of this mobile app will be related to a developer to create this healthcare mobile application that will hence be called IFEORTHOCARE APP. It will be a healthcare mobile application that is intended to improve patient compliance with pre-determined dental prescriptions by helping the patient (that will hence be referred to as users), better track and log their day-to-day tooth-brush sessions. These log entries will then be analyzed and better fine-tuned to highlight relevant metrics and as well, feed back to the orthodontist-in-charge in a format that can be accessed in near real time from a centralized dashboard. Target Platform will comprise android for patients and web for the orthodontists/administrators. The android platform’s front end programme will be JAVA enhanced and its database will make use of Extendable Markup Language (XML) and Android SQLite. The description/Screens of graphic user interface (GUI) from the beginning of the app for user will include registration, sign in, home screen, setting screen, timer screen and user’s profile 22
Control Group Verbal oral hygiene instruction Given during clinic visit Four clinic sessions spend quality time when you brush your teeth and remember to brush for at least three minutes in the morning, afternoon and evening; always use a fluoride toothpaste and regular medium textured brush; you are to place the bristles at the gingival margin, pointing at 45-degree angle to the long axis of the teeth, exert gentle vibratory pressure, using short, back-and-forth motions for five times without dislodging the tips of bristles and then make occlusal sweep for another five times ; while Group A will use the developed mobile app for their instructions. 3. Patients will be instructed to avoid candies, carbonated soft drinks and acidic juices during treatment. 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
INCLUSION CRITERIA 1. Patients with malocclusion that require fixed orthodontic therapy. 2. Patients aged 12 years and above 3. Patients who own smart mobile phone 4. Patients that have not taken antibiotics for 3 months before the baseline examination and during treatment. 5. Patients with no signs of gingival inflammation at baseline. 6. Patients with no physical and mental disorders. 7. Patients without veneers, crowns or bridge. EXCLUSION CRITERIA 1. Smokers 2. Pregnant or lactating women 3. Patients using medication such as Phenytoin for managing chronic diseases like epilepsy 4. Patients who have undergone periodontal treatment such as root planing, curettage and perio-surgery within 3 months before the baseline examination 5. Patients with a systemic disorder that could influence periodontal and microbiologic conditions or response to treatment such as uncontrolled diabetes mellitus. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 12 Year(s) 35 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 21/10/2019 ETHIC AND RESEARCH COMMITTEE OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
Opposite Oranfe Street Ile Ife 22005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcome measurement A primary outcome will be assessed using Orthodontic Plaque Index (OPI). The OPI will be used to record the presence of dental biofilm around the brackets of the fixed appliance. This will be aided by prior staining of the teeth or surfaces with a plaque-disclosing solution. The evaluation will include only teeth or surfaces that bear an adhesively bonded bracket on the buccal aspect. Teeth bearing orthodontic bands will not be included. The dentition will be divided into sextants. The status of biofilm accumulation will be graded from 0 to 4. The degree of plaque accumulation on each aspect of the bracket base (mesial, distal, occlusal / incisal, and cervical) and the condition of the adjacent marginal gingivae will be assessed. 0: No plaque deposits on the tooth surfaces surrounding the bracket base; 1: Plaque deposits on one tooth surface at the bracket base; 2: Plaque deposits on two tooth surfaces at the bracket base; 3: Plaque deposits on three tooth surfaces at the bracket base; 4: Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators. The highest score per sextant will be entered into the sextant table. In addition, the highest score per sextant represents the score for the dentition. 4 weeks, 8 weeks 12 weeks
Secondary Outcome Secondary outcome measurement The secondary outcomes will be measured using Gingival Index (GI) and White spot lesion index (WSL I). Gingival Index by Löe (1967) This will utilize all Ramfjord teeth (maxillary right first molar, maxillary left central incisor, maxillary left first premolar, mandibular left first molar, mandibular right central incisor, and mandibular right first premolar) to evaluate the gingival health for each participant at each point in time. Each tooth will be examined at six surfaces (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual). It scores the marginal and interproximal tissues separately on the basis of 0 to 3. The criteria are: 0= Normal gingiva; 1= Mild inflammation – slight change in colour and slight edema but no bleeding on probing; 2= Moderate inflammation – redness, edema and glazing, bleeding on probing; 3= Severe inflammation – marked redness and edema, ulceration with tendency to spontaneous bleeding 4 weeks, 8 weeks and 12 weeks
Secondary Outcome White Spot Lesion Index This will be assessed according to the WSL index of Gorelick et al.13 The labial surfaces of all bonded teeth will be visually examined and registered as: 1: No white spot formation 2: Slight white spot formation (thin rim) 3: Excessive white spot formation (thicker bands) 4: White spot formation with cavitation. 4 weeks, 8 weeks and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex. Opposite Oranfe Street Ile Ife 22005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adesunloye Adebisi 4, Fawole street Ile ife 22005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adesunloye Adebisi 4 Fawole Street, Ile Ife 22005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
4Ayodeji Odudola Oluwatope Road 24, House 18, OAU Staff quaters Ile ife 22005 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adebisi Adesunloye adebisiadesuloye32@gmail.com +2348033767956 4 Fawole Street
City Postal code Country Position/Affiliation
Ile Ife 22005 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olayinka Otuyemi ootuyemi@yahoo.com +2348037191734 Road 23 senior staff quater, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 22005 Nigeria Professor
Role Name Email Phone Street address
Scientific Enquiries Solomon Olusegun Nwhator periodontologist2010@gmail.com +2348150611227 Opposite Oranfe Street
City Postal code Country Position/Affiliation
Ile Ife 22005 Nigeria Senior lecturer and specialist Periodontologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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
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