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The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

Primary Purpose

Gingivitis

Status
Recruiting
Phase
Phase 3
Locations
Iraq
Study Type
Interventional
Intervention
interdental brush
single tufted brush
water irrigator
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Dental plaque, Interdental brush, Single tufted brush, Water irrigator

Eligibility Criteria

14 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OlaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

interdental tooth brush

single tufted brush

water irrigator

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

Change in BOP score
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
change in Gingival index
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.
change in plaque index
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 Outcome Measures

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

Full Information

First Posted
May 11, 2023
Last Updated
June 3, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05889975
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Dental plaque, Interdental brush, Single tufted brush, Water irrigator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
the examiner will be blinded to type of intervention given to the participants. Each intervention will be given a code which will be concealed by a third-party who have no role in the study. The codes will be declared at the end of the study during data analysis.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interdental tooth brush
Arm Type
Active Comparator
Arm Description
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.
Arm Title
single tufted brush
Arm Type
Active Comparator
Arm Description
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.
Arm Title
water irrigator
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
interdental brush
Intervention Description
cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days
Intervention Type
Device
Intervention Name(s)
single tufted brush
Intervention Description
cleaning the inter dental areas after manual tooth brush twice daily by the patient for 30 days
Intervention Type
Device
Intervention Name(s)
water irrigator
Intervention Description
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 Outcome Measure Information:
Title
Change in BOP score
Description
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
Time Frame
0-30 Days
Title
change in Gingival index
Description
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.
Time Frame
0 -30 Days
Title
change in plaque index
Description
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
Time Frame
0-30 days
Secondary Outcome Measure Information:
Title
Mean relative change in macrophage migration inhibition level in salivary Fluid
Description
Mean relative change in macrophage migration inhibition level in salivary Fluid after brashing with different comparators from baseline at 30 days
Time Frame
0-30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ola issam aljanabi, master
Phone
07730090353
Email
Ola.issam95jx147@gmail.com
Facility Information:
Facility Name
Ola
City
Baghdad
ZIP/Postal Code
iraq
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ola Issam aljanabi
Phone
07730090353
Email
Ola.issam95jx147@gmail.com
First Name & Middle Initial & Last Name & Degree
ola issam aljanabi, master

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

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