Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643236
• Other study ID #: 2017/151
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2020
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Periodontal Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.