GingivitisNCT04643236
Increased Knowledge Improve Oral Hygiene In Patients With Gingivitis
A study testing Periodontal health education session and Oral hygiene motivation session in people with Gingivitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Gingivitis
- What is being tested?
- Periodontal health education session and Oral hygiene motivation session
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Periodontology
Bolu, 14030
About this study
Official title: Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Periodontal health education session, Oral hygiene motivation session
- Keywords
- motivational interview, periodontal disease, oral hygiene
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal health education sessionBehavioural
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 sessionBehavioural
Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.
| Study group | Role | What they receive |
|---|---|---|
| periodontal health educational group (test) | Experimental | 25 subjects diagnosed with gingivitis received periodontal health education session Receives: Behavioral: Periodontal health education session |
| oral hygiene motivation group (control) | Active comparator | 25 subjects diagnosed with gingivitis received standard oral hygiene motivation session Receives: Behavioral: Oral hygiene motivation session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Feb 2018
- Primary completion1 Apr 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Single-Centre, Randomised, Parallel Design Controlled Clinical Study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadiye Gunpinar, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643236
- Sponsor's protocol ID
- 2017/151
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available now.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Knowledge About The Pathogenesis Of Periodontal Disease Improve Oral Hygiene In Patients With Gingivitis-A Blinded Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04643236
- Acronym / sponsor ID
- 2017/151
- Conditions
- Gingivitis
- Keywords
- motivational interview, periodontal disease, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Single-Centre, Randomised, Parallel Design Controlled Clinical Study
| Arm | Type | Receives |
|---|---|---|
| periodontal health educational group (test) | Experimental | Behavioral: Periodontal health education session25 subjects diagnosed with gingivitis received periodontal health education session |
| oral hygiene motivation group (control) | Active comparator | Behavioral: Oral hygiene motivation session25 subjects diagnosed with gingivitis received standard oral hygiene motivation session |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal health education sessionThis 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. | Behavioural | periodontal health educational group (test) |
| Oral hygiene motivation sessionStandard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment. | Behavioural | oral hygiene motivation group (control) |
Primary outcome
Change in Rustogi Modified Navy Plaque index (RMNPI) scores
Time frame: 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.
1 secondary outcome
Change in Papillary bleeding index (PBI) scores
Time frame: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available now.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal health education session and Oral hygiene motivation session in people with Gingivitis, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rustogi Modified Navy Plaque index (RMNPI) scores (time frame: Measured at Baseline and at 1st-, at 3rd- and at 6th month after nonsurgical periodontal treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.