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EFFECT OF ORAL HYGIENE INSTRUCTION MOBILE APPLICATION ON THE ORAL HEALTH OF PATIENTS UNDERGOING FIXED ORTHODONTIC TREATMENT: A RANDOMISED CLINICAL TRIAL

EFFECT OF ORAL HYGIENE INSTRUCTION MOBILE APPLICATION ON THE ORAL HEALTH OF PATIENTS UNDERGOING FIXED ORTHODONTIC TREATMENT: A RANDOMISED CLINICAL TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202112595280782
Enrollment
42
Registered
2021-12-10
Start date
2020-03-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Interventions

The use of mobile apps named IFEORTHOCARE mobile app to improve oral hygiene of patients.

Sponsors

Adesunloye Adebisi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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 ;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.

Countries

Nigeria

Contacts

Public ContactOlayinka Otuyemi

Professor

ootuyemi@yahoo.com+2348037191734

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026