Can vitamin supplements help school children in healing gum diseases?
| ISRCTN | ISRCTN18356310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18356310 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 00001 |
| Sponsor | University of Lahore |
| Funder | Investigator initiated and funded |
- Submission date
- 31/05/2025
- Registration date
- 05/08/2025
- Last edited
- 13/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gum disease is very common in Pakistani children. Along with the lack of dental hygiene awareness and regular checkups, deficiencies in micronutrients like vitamin C and D are also widespread among children. This study aimed to assess whether correcting the micronutrient deficiency alongside normal dental care would improve periodontal disease progression in school-age children.
Who can participate?
School-going children aged 4-12 years with no systemic illnesses
What does the study involve?
First visit (baseline): each child (and a parent) answers a short questionnaire about home dental habits, demographics, and vitamin deficiency and then has a dental checkup.
Group allocation:
Group A (control): professional ultrasonic scaling + dental hygiene advice.
Group B (vitamin C and D deficient group ): the same scaling and advice plus vitamin C & D supplements.
Follow-up visits: after 4 weeks and again after 8 weeks the dentists re-measure the Gingival Index and pocket depth. All children receive the same brushing advice at every visit.
What are the possible benefits and risks of participating?
Benefits: free dental scaling, personalised brushing tips, and (for Group B) free vitamin supplements that may reduce the severity of gum disease.
Risks: scaling can feel a little sensitive and vitamins can occasionally cause mild stomach upset, but no serious risks are expected. The university ethics board has stated that there is no disadvantage or risk for participants and families may leave the study at any time.
Where is the study run from?
Dental examinations take place in selected primary schools in Lahore and at the University Dental Hospital, University College of Medicine & Dentistry (UCMD), The University of Lahore (Pakistan).
When is the study starting and how long is it expected to run for?
September 2021 to February 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Arooj ul Hassan, arooj.ulhassan@ucd.uol.edu.pk, aroojch678@hotmail.com
Contact information
Public, Scientific, Principal investigator
227-A, Military accounts
College Road
Lahore
54000
Pakistan
| Phone | +92 (0)3444420953 |
|---|---|
| arooj.ulhassan@ucd.uol.edu.pk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Effectiveness of Vitamin C and Vitamin D supplements in the treatment of periodontal diseases in school-going children |
| Study acronym | Eff-Vit-Per-Kids |
| Study objectives | Appropriate supplementation with Vitamin C and Vitamin D improves periodontal health in school-going children by reducing inflammation, enhancing immune response, and promoting tissue healing. |
| Ethics approval(s) | Approved 17/01/2019, Institutional Review Board, Faculty of Allied Health Sciences, The University of Lahore, 1-Km, Defence Road Campus, Off Bhobatian Chowk, Lahore, 54000, Pakistan, +924235322501-12, info@uol.edu.pk, ref: IRB-UOL-FAHS/83511/2019 |
| Health condition(s) or problem(s) studied | Periodontal disease |
| Intervention | Cross-sectional phase 1 for baseline assessment followed by interventional phase 2 with modified RCT protocol among two groups (Group A with non-deficient children and group B with deficient children) to allow for intervention to only be given to children who were deficient, blinding done by switching of examiners between baseline assessment, intervention and follow-up examination. First visit (baseline): each child (and a parent) answers a short questionnaire about home dental habits, demographics, and vitamin deficiency and then has a dental checkup. Group allocation: Group A (control): professional ultrasonic scaling + dental hygiene advice. Group B (vitamin C and D deficient group): the same scaling and advice plus vitamin C and D supplements. Follow-up visits: after 4 weeks and again after 8 weeks the dentists re-measure the Gingival Index and pocket depth. All children receive the same brushing advice at every visit. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Gingival health measured using the Silness-Loe Gingival Index (GI) at baseline, 4 and 8 weeks |
| Key secondary outcome measure(s) |
Probing depth measured using a Williams probe on a periodontal chart at baseline, 4 and 8 weeks |
| Completion date | 05/02/2024 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 306 |
| Total final enrolment | 200 |
| Key inclusion criteria | 1. School-going children 2. No systemic diseases 3. Not taking antibiotic therapy 4. 4-12 years of age |
| Key exclusion criteria | 1. Participants with systemic disease like diabetes or otherwise immunocompromised 2. Participants taking antibiotics |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 03/11/2021 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Lahore
54000
Pakistan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Arooj ul Hassan (aroojch678@hotmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/06/2025: Study's existence confirmed by the Institutional Review Board, University College of Dentistry.
