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Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

NCT ID: NCT04643236

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-11-01

Brief Summary

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Proper plaque control is essential for to maintain oral and general health therefore, improving patient motivation is crucial for to prevent oral diseases including periodontal diseases. The aim of this clinical trial is to evaluate the effect of periodontal health education session (PHES) including the pathogenesis and consequences of periodontal diseases on oral hygiene motivation in patients with gingivitis.

Detailed Description

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A randomized controlled clinical trial design with 50 subjects (26 Females and 24 males) was carried out in a group of gingivitis patients who underwent periodontal treatment. Subjects were randomly allocated into PHES group (test, n = 25) and standard oral hygiene education group (OHE) (control, n=25). Test group received information about the pathogenesis of periodontal diseases, its consequences, its interaction with systemic diseases and the importance of daily proper cleaning by experienced periodontologist via brochure. Control group received only standard oral hygiene instructions. The Rustogi Modified Navy Plaque index (RMNPI) and papillary bleeding index (PBI) were utilized to evaluate the oral hygiene at baseline and repeated at 1, 3 and 6 months follow-up.

The clinical outcome variables of RMNPI (primary outcome) and PBI (secondary outcome) scores were analysed with Mann Whitney U test. Friedman-Wilcoxon sign ranked test was used for within group comparison. All data were analysed using the Statistical software (SPSS, version 19.0, Chicago, IL, USA). A p-value of \<0.05 was accepted as statistical significance.

Conditions

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Gingivitis

Keywords

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motivational interview periodontal disease oral hygiene

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Single-Centre, Randomised, Parallel Design Controlled Clinical Study
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
A total of 50 sealed envelopes were prepared in which the group names were written. Following, they were separated in two plastic boxes equally. The group of each participant was recorded by the first author whom the educational intervention was performed (SG). The examiner who performed the clinical process (BM) was unaware of the groups

Study Groups

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periodontal health educational group (test)

25 subjects diagnosed with gingivitis received periodontal health education session

Group Type EXPERIMENTAL

Periodontal health education session

Intervention Type BEHAVIORAL

This session comprised of a condensed version of motivational interviewing and a periodontal education view/point. First, patients were analysed in terms of expectations from periodontal treatment/oral hygiene practice, knowledge about periodontal diseases and its consequences, daily oral hygiene routine, awareness of the current periodontal status and the main reasons for not doing proper brushing and interproximal cleaning. The same researcher who did not included in the clinic process informed the patients about how periodontal diseases develops, its aetiology, symptoms, consequences and the relationship with the important systemic disorders verbally and via brochure as well. The importance of the patients' own efforts about daily cleaning of the mouth were emphasized. Finally oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.

oral hygiene motivation group (control)

25 subjects diagnosed with gingivitis received standard oral hygiene motivation session

Group Type ACTIVE_COMPARATOR

Oral hygiene motivation session

Intervention Type BEHAVIORAL

Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.

Interventions

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Periodontal health education session

This session comprised of a condensed version of motivational interviewing and a periodontal education view/point. First, patients were analysed in terms of expectations from periodontal treatment/oral hygiene practice, knowledge about periodontal diseases and its consequences, daily oral hygiene routine, awareness of the current periodontal status and the main reasons for not doing proper brushing and interproximal cleaning. The same researcher who did not included in the clinic process informed the patients about how periodontal diseases develops, its aetiology, symptoms, consequences and the relationship with the important systemic disorders verbally and via brochure as well. The importance of the patients' own efforts about daily cleaning of the mouth were emphasized. Finally oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.

Intervention Type BEHAVIORAL

Oral hygiene motivation session

Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with gingivitis (no clinical attachment loss) and no previous periodontal treatment,
* non-smokers,
* aged\>22 years old and who have a university degree,
* had a visible plaque level \> 50%.

Exclusion Criteria

* Patients having systemic conditions that could affect the healing process and prevent the application of oral hygiene instructions,
* Patients rehabilitated with teeth/implant supported prostheses,
* Patients diagnosed with periodontitis,
* Patients having defective restorations/active teeth related infection or ongoing orthodontic treatment
* Patients who had to be out of the city in a long time during the study period.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Sadiye Gunpinar

Asst.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2017/151

Identifier Type: -

Identifier Source: org_study_id