Clinical trial NCT04643236: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: motivational interview
periodontal disease
oral hygiene
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Single-Centre, Randomised, Parallel Design Controlled Clinical Study
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Rustogi Modified Navy Plaque index (RMNPI) scores
timeFrame: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
Secondary outcomes:
measure: Change in Papillary bleeding index (PBI) scores
timeFrame: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
Study officials:
References: