Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Behavioral: Periodontal health education session; Behavioral: Oral hygiene motivation session

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey, 14030
    • Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: periodontal health educational group (test); 25 subjects diagnosed with gingivitis received periodontal health education session	Behavioral: 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.
ACTIVE_COMPARATOR: oral hygiene motivation group (control); 25 subjects diagnosed with gingivitis received standard oral hygiene motivation session	Behavioral: Oral hygiene motivation session; Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Rustogi Modified Navy Plaque index (RMNPI) scores	The facial/lingual surfaces of each teeth was divided in nine region and scored as 0: absence of plaque and 1: existence of plaque. The averages of the sum of those scores were evaluated per patient as total (A+B+C+D), gingival margin associated (A+B+C) and interproximal region associated plaque above the margin (D+F). Furthermore, the indicator of proper interproximal cleaning surface area (A+C+D+F) was also evaluated per patient. The change in RMNPI scores between all time intervals were evaluated and compared between study groups.	Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Papillary bleeding index (PBI) scores	Each papilla region was scored and the mean of those scores were recorded as PBI per patient. Accordingly, 0: no bleeding; 1: a single isolated bleeding point; 2: several isolated bleeding points; 3: interdental triangle fills with blood soon after probing; 4: intense bleeding occurs immediately after probing through the gingival margin. The change in PBI scores between all time intervals were evaluated and compared between the study groups.	Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: periodontal disease; oral hygiene; motivational interview
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Periodontal Diseases
• Other Study ID Numbers: 2017/151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available now.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No