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Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Periodontal health education session
Oral hygiene motivation session
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring motivational interview, periodontal disease, oral hygiene

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

periodontal health educational group (test)

oral hygiene motivation group (control)

Arm Description

25 subjects diagnosed with gingivitis received periodontal health education session

25 subjects diagnosed with gingivitis received standard oral hygiene motivation session

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 13, 2020
Last Updated
November 18, 2020
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT04643236
Brief Title
Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis
Official Title
Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
motivational interview, periodontal disease, oral hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Single-Centre, Randomised, Parallel Design Controlled Clinical Study
Masking
InvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
periodontal health educational group (test)
Arm Type
Experimental
Arm Description
25 subjects diagnosed with gingivitis received periodontal health education session
Arm Title
oral hygiene motivation group (control)
Arm Type
Active Comparator
Arm Description
25 subjects diagnosed with gingivitis received standard oral hygiene motivation session
Intervention Type
Behavioral
Intervention Name(s)
Periodontal health education session
Intervention Description
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
Intervention Name(s)
Oral hygiene motivation session
Intervention Description
Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.
Primary Outcome Measure Information:
Title
Change in Rustogi Modified Navy Plaque index (RMNPI) scores
Description
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.
Time Frame
Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
Secondary Outcome Measure Information:
Title
Change in Papillary bleeding index (PBI) scores
Description
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.
Time Frame
Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
City
Bolu
ZIP/Postal Code
14030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available now.

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Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

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