Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis

NCT04643236 | Completed DMC

• 1 other identifier: 2017/151
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

motivational interview; periodontal disease; oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Papillary bleeding index (PBI) scores

  Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.

Study Arms (2)

periodontal health educational group (test)

EXPERIMENTAL

25 subjects diagnosed with gingivitis received periodontal health education session

Behavioral: Periodontal health education session

oral hygiene motivation group (control)

ACTIVE COMPARATOR

25 subjects diagnosed with gingivitis received standard oral hygiene motivation session

Behavioral: Oral hygiene motivation session

Interventions

Periodontal health education session BEHAVIORAL

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.

periodontal health educational group (test)

Oral hygiene motivation session BEHAVIORAL

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

oral hygiene motivation group (control)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof.

Model Details: A Single-Centre, Randomised, Parallel Design Controlled Clinical Study

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 25, 2020
• Study Start: February 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)