Gingival DiseaseNCT03723174
Impact of an Educational Program on Gingival Status and Oral Health Related Quality of Life
An observational study of Gingival Disease and Oral Disease, run by Cairo University at 1 site in Egypt.
Trial summary
This research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the Egyptian population. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Disease, Oral Disease
- What is being tested?
- Oral Health Educational Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 91 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 30 May 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged from 11 to 14 years old seeking dental care at the educational hospital, Department of Pediatric Dentistry and Dental Public Health, School of Dentistry New Giza University.
Who may be able to join
- Patients aged from 11-14 years old
- No reported systemic disease
- No administration of antibiotics in the last month
- No fixed or removable appliance
- Absence of acute phase of any oral disease
Who cannot join
- Patient refuses to participate in the study
- patient fails to attend follow up sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Educational Program on Oral Health Related Quality of Life in a Group of 11 to 14 Years Old Egyptian Children: Before and After Study.
This research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the Egyptian population. Each participant will benefit from the education of the proper oral hygiene practices under the supervision and follow up of the investigator in addition to the potential improvement of his/ her oral health related quality of life.
Read the detailed description
The objective of this study is to improve the gingival status and oral health related quality of life in the Egyptian population's early adolescence. The intervention is an Oral health educational program based on the following:
- Tooth brushing: the modified bass technique is the method of choice the skill will be taught using a video followed by a model demonstration then a supervised brushing session done by the participants.
- Dietary recommendations and importance of visiting the dentist will be introduced in the form of power point presentation that will be set according to the American Academy of Pediatric Dentistry (AAPD).
- Participant will be asked to come for 4 visits one for base line data collection and administration of the intervention and another 3 follow up visits once per month.
- Conditions
- Gingival Disease, Oral Disease
- Being tested
- Oral Health Educational Program
- Medical subject headings
- Gingival Diseases, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Educational ProgramBehavioural
proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | baseline data will be calculated before the oral health educational program using gingival index and after 3 months from the intervention Receives: Behavioral: Oral Health Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short form Child perception questionnaire 11-14
assessment of Oral symptoms, functional limitations, emotional and social well being. each domain scores from 0-20 where 20 means the worst quality of life in each domain.
Measured: 3 months
Secondary outcomes (1)
Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021
assessment of Swelling of gingiva red color characteristics using number of red pixels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Nov 2020
- Primary completion20 Mar 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fayrouz Saber, Cairo University
- Investigators
- Manal Al Sayed, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723174
- Sponsor's protocol ID
- fay
- Status last verified
- Jul 2021
- First submitted
- 25 Oct 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhardwaj VK, Sharma KR, Luthra RP, Jhingta P, Sharma D, Justa A. Impact of school-based oral health education program on oral health of 12 and 15 years old school children. J Educ Health Promot. 2013 Jul 31;2:33. doi: 10.4103/2277-9531.115820. eCollection 2013.
PubMed 24083283Smith RN, Lath DL, Rawlinson A, Karmo M, Brook AH. Gingival inflammation assessment by image analysis: measurement and validation. Int J Dent Hyg. 2008 May;6(2):137-42. doi: 10.1111/j.1601-5037.2008.00294.x.
PubMed 18412727Mostafa B, El-Refai I. Prevalence of Plaque-Induced Gingivitis in a Sample of the Adult Egyptian Population. Open Access Maced J Med Sci. 2018 Mar 10;6(3):554-558. doi: 10.3889/oamjms.2018.131. eCollection 2018 Mar 15.
PubMed 29610619
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Educational Program on Oral Health Related Quality of Life in a Group of 11 to 14 Years Old Egyptian Children: Before and After Study.
- ClinicalTrials.gov ID
- NCT03723174
- Acronym / sponsor ID
- fay
- Conditions
- Gingival Disease, Oral Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 29 Oct 2018 (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.
This research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the Egyptian population. Each participant will benefit from the education of the proper oral hygiene practices under the supervision and follow up of the investigator in addition to the potential improvement of his/ her oral health related quality of life.
Detailed description
The objective of this study is to improve the gingival status and oral health related quality of life in the Egyptian population's early adolescence. The intervention is an Oral health educational program based on the following:
- Tooth brushing: the modified bass technique is the method of choice the skill will be taught using a video followed by a model demonstration then a supervised brushing session done by the participants.
- Dietary recommendations and importance of visiting the dentist will be introduced in the form of power point presentation that will be set according to the American Academy of Pediatric Dentistry (AAPD).
- Participant will be asked to come for 4 visits one for base line data collection and administration of the intervention and another 3 follow up visits once per month.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Behavioral: Oral Health Educational Programbaseline data will be calculated before the oral health educational program using gingival index and after 3 months from the intervention |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged from 11 to 14 years old seeking dental care at the educational hospital, Department of Pediatric Dentistry and Dental Public Health, School of Dentistry New Giza University.
Key inclusion criteria (5 listed)
- Patients aged from 11-14 years old
- No reported systemic disease
- No administration of antibiotics in the last month
- No fixed or removable appliance
- Absence of acute phase of any oral disease
Key exclusion criteria (2 listed)
- Patient refuses to participate in the study
- patient fails to attend follow up sessions
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 |
|---|---|---|
| Oral Health Educational Programproper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist | Behavioural | Single Arm |
Primary outcome
Short form Child perception questionnaire 11-14
Time frame: 3 months
assessment of Oral symptoms, functional limitations, emotional and social well being. each domain scores from 0-20 where 20 means the worst quality of life in each domain.
1 secondary outcome
Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021
Time frame: 3 months
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 2 Aug 2021.
- Background: PubMed 24083283Bhardwaj VK, Sharma KR, Luthra RP, Jhingta P, Sharma D, Justa A. Impact of school-based oral health education program on oral health of 12 and 15 years old school children. J Educ Health Promot. 2013 Jul 31;2:33. doi: 10.4103/2277-9531.115820. eCollection 2013.
- Background: PubMed 18412727Smith RN, Lath DL, Rawlinson A, Karmo M, Brook AH. Gingival inflammation assessment by image analysis: measurement and validation. Int J Dent Hyg. 2008 May;6(2):137-42. doi: 10.1111/j.1601-5037.2008.00294.x.
- Results publication: PubMed 29610619Mostafa B, El-Refai I. Prevalence of Plaque-Induced Gingivitis in a Sample of the Adult Egyptian Population. Open Access Maced J Med Sci. 2018 Mar 10;6(3):554-558. doi: 10.3889/oamjms.2018.131. eCollection 2018 Mar 15.
- Individual participant dataSharing planned: No
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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.
Manal Al Sayed, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Disease and Oral Disease, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 2 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 2 Aug 2021. 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 Egypt. 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?
Short form Child perception questionnaire 11-14 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723174, which also lists 3 linked publications.
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 2 Aug 2021.