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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03723174
Other study ID # fay
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date May 30, 2021

Study information

Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date May 30, 2021
Est. primary completion date March 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria: 1. Patients aged from 11-14 years old 2. No reported systemic disease 3. No administration of antibiotics in the last month 4. No fixed or removable appliance 5. Absence of acute phase of any oral disease Exclusion Criteria: 1. Patient refuses to participate in the study 2. patient fails to attend follow up sessions

Study Design


Intervention

Behavioral:
Oral Health Educational Program
proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist

Locations

Country Name City State
Egypt New Giza University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Mostafa 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. — View Citation

Smith 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 months
Secondary Photographic evaluation and interpretation using Adobe Photoshop Creative Cloud 2021 assessment of Swelling of gingiva red color characteristics using number of red pixels 3 months
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