The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

February 19, 2024 updated by: Ola Issam Majeed Aljanabi, University of Baghdad

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

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 .

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Baghdad, Iraq, iraq
        • Ola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days
Active Comparator: 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.
cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-30 Days
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.
0 -30 Days
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
0-30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

April 8, 2023

Study Completion (Actual)

June 5, 2023

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 3, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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