The Efficacy of Different Adjunctive Plaque Control Modalities in Orthodontic Patients

NCT05889975 | Completed Phase 3

• 1 other identifier: 738622
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Gingivitis

Keywords

Dental plaque; Interdental brush; Single tufted brush; Water irrigator

Outcome Measures

Primary Outcomes (3)

• 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

  0-30 Days

• 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.

  0 -30 Days

• 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

  0-30 days

Secondary Outcomes (1)

• Mean relative change in macrophage migration inhibition level in salivary Fluid

  0-30 days

Study Arms (3)

interdental tooth brush

ACTIVE COMPARATOR

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.

Device: interdental brush

single tufted brush

ACTIVE COMPARATOR

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.

Device: single tufted brush

water irrigator

ACTIVE COMPARATOR

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.

Device: water irrigator

Interventions

interdental brush DEVICE

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

interdental tooth brush

single tufted brush DEVICE

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

single tufted brush

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

water irrigator

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Ola

Baghdad, iraq, Iraq

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 5, 2023
• Study Start: January 9, 2023
• Primary Completion: April 8, 2023
• Study Completion: June 5, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

IR (1)