Skip to main content
OpenTrials
Completed

NCT Number: NCT05889975

The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingivitis Dental Deposits Dental Plaque Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ola

Baghdad, iraq, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interdental Brush

Device

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

single tufted brush

Device

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

water irrigator

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

Primary outcomes

  1. Change in BOP score

    Time frame: 0-30 Days

    For recording BOP score, the periodontal probe was inserted with gentle force into the sulcus/pocket until minimal resistance was felt. The probing force presumably was ranging between 20 to 25g. The examination started from the distal surface of the right upper 7 moving mesially to measure all the existing teeth. For each tooth, 6 surfaces were examined; the surface that displayed bleeding on probing was scored 1 and the surface with no bleeding was scored 0

  2. change in Gingival index

    Time frame: 0 -30 Days

    Subjects will undergo the measurement of gingival index according to Loe & Silness, designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Data will be collected based on four possible clinical conditions: 0=Normal gingiva1=Mild Inflammation-Slight change in color, Slight odema. No bleeding on probing2=Moderate inflammation-redness,odema and glazing. Bleeding on probing 3=Sever inflammation-marked redness and edema.Ulceration.Tendency to spontaneous bleeding.

  3. change in plaque index

    Time frame: 0-30 days

    Mean amount plaque between different comparators. Mean amount plaque between different comparators as anti-plaque agent after rinsing with different comparators using means of modified quigely hein plaque index[ Turesky ,1970

Secondary outcomes

  1. Mean relative change in macrophage migration inhibition level in salivary Fluid

    Time frame: 0-30 days

    Mean relative change in macrophage migration inhibition level in salivary Fluid after brashing with different comparators from baseline at 30 days

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients: a 30 Days Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.