Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Behavioral: Oral hygiene motivation session; Behavioral: Periodontal health education session

• Registration Number: NCT04643236
• Lead Sponsor: Abant Izzet Baysal University

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.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-11-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-25
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral hygiene motivation group (control)	Oral hygiene motivation session	25 subjects diagnosed with gingivitis received standard oral hygiene motivation session
periodontal health educational group (test)	Periodontal health education session	25 subjects diagnosed with gingivitis received periodontal health education session

Primary Outcome Measures

Name	Time	Method
Change in Rustogi Modified Navy Plaque index (RMNPI) scores	Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.	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

Name	Time	Method
Change in Papillary bleeding index (PBI) scores	Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.	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.

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology; 🇹🇷 Bolu, Turkey