Clinical trial NCT05889975: The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients
Official title: The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients: a 30 Days Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingivitis
Keywords: Dental plaque
Interdental brush
Single tufted brush
Water irrigator
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Bacterial plaque is the primary etiological factor for periodontal disease ranging from mild gingival inflammation to severe periodontitis.The fixed appliance can alter the microbial composition of the oral environment.Patients who wear fixed braces must perform optimum oral hygiene techniques .using a regular toothbrush alone for plaque removal is important but it is not adequate;therefore,an Adjunctive Plaque Control such as inter dental brush ,single tufted brush and water irrigator are helpful.the objective of this study To compare the efficacy of water irrigator ,single tufted and interdental brush in reducing gingival inflammation and plaque accumulation and To determine the profile of the salivary (MIF) at base line visit and after 4 weeks of the study .

Detailed description: Bacterial plaque has been widely demonstrated to be the primary etiological factor for periodontal disease ranging from mild gingival inflammation to severe periodontitis .

The fixed appliance can alter the microbial composition of the oral environment, promoting bacterial plaque retention, decreasing self-cleaning skills, and causing gingival infection or enamel decalcification, as well as white spot lesions with soft-tissue recession and tooth abrasion.Patients who wear fixed braces must perform optimum oral hygiene techniques to avoid a variety of problems, including as caries, enamel demineralization, gingivitis, gingival hyperplasia, and periodontitis .

Plaque removal using a toothbrush is an efficient way to prevent decalcification. However, it is unclear whether using a regular toothbrush alone is adequate for plaque removal. Some authorities have suggested for the use of interdental/interspace brushes to eliminate plaque from 'hard to reach' places .There is some evidence show that interdental brushes decrease plaque in interdental regions in patients with pocketing, interdental spaces, and bridges. However; interspace and interdental brushes are small-headed toothbrushes with bristles that can clean small regions that standard toothbrushes cannot reach.

The removal of plaque has been proven to be safe and efficient with water flossers, as reported by the American Dental Association (ADA). A water flosser can also minimize gingivitis.Single-tufted toothbrushes are suggested for cleaning free surfaces and parts of the teeth that are difficult to reach with other oral hygiene tools.

Eligibility criteria: Inclusion Criteria:

* patients wearing fixed stainless steel orthodontic appliances in upper and lower jaw aving minimum of 20 teeth
* non-smoker with no history of any systemic disease and patients
* did not receive medical treatment in the last three months prior to the examination and sampling.

Exclusion Criteria:

* Patients with other type of orthodontic appliance rather than fixed appliance or patients having dental crowns or bridges
* handicapped patient or patients with limited manual dexterities
* pregnant or lactating women
* periodontitis patient
* patients unwilling to participate in study

Primary outcomes:
measure: Change in BOP score
timeFrame: 0-30 Days
measure: change in Gingival index
timeFrame: 0 -30 Days
measure: change in plaque index
timeFrame: 0-30 days
Secondary outcomes:
measure: Mean relative change in macrophage migration inhibition level in salivary Fluid
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ola
Study officials:
References: