The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

NCT ID: NCT05889975

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-06-05

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

interdental tooth brush

the patients will be instructed to brush their teeth for 2 minutes with a pea- size amount of dentifrice twice daily,then the brush will be used after completion of manual tooth brushing it will be gently inserted between the teeth and orthodontic appliance, the patient will be instructed to use appropriate size brush and a smaller brush size if it feels too tight.

Group Type: ACTIVE_COMPARATOR

interdental brush

Intervention Type: DEVICE

cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days

single tufted brush

the patients will be instructed to brush their teeth for 2 minutes with a pea- size amount of dentifrice twice daily,then the brush will be used after completion of manual tooth brushing it will be gently inserted between the teeth and orthodontic appliance.

Group Type: ACTIVE_COMPARATOR

single tufted brush

Intervention Type: DEVICE

cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days

water irrigator

the patients will be instructed to brush their teeth for 2 minutes with a pea- size amount of dentifrice twice daily,thenThe patients will be instructed to use water irrigator after manual tooth brushing with 300ml distal water placed in its container. The patients instructed to use the entire 300ml during each irrigation.

Group Type: ACTIVE_COMPARATOR

water irrigator

Intervention Type: DEVICE

using water irrigator after manual tooth brushing twice daily with 300ml distal water placed in its container. The patients instructed to use the entire 300ml during each irrigation for 30 days

Interventions

interdental brush

cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days

Intervention Type: DEVICE

single tufted brush

cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days

Intervention Type: DEVICE

water irrigator

using water irrigator after manual tooth brushing twice daily with 300ml distal water placed in its container. The patients instructed to use the entire 300ml during each irrigation for 30 days

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Ola Issam Majeed Aljanabi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ola

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

738622

Identifier Type: -

Identifier Source: org_study_id