- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05889975
The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients
The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients: a 30 Days Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: ola issam aljanabi, master
- Phone Number: 07730090353
- Email: Ola.issam95jx147@gmail.com
Study Locations
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-
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Baghdad, Iraq, iraq
- Ola
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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
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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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 738622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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