Optimal dental and gum care during routine orthodontic treatment Oral Health
Conditions
Interventions
Participants will be randomly assigned to intervention care [IC] and standardised care [SC] and assessed at baseline, 1-, 6- and 12-months, with the final scoring being at the removal of fixed braces
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
12 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Adolescents [12-16 years] of all ethnicity, socio-economic grouping and gender, for whom parents are able and willing to give informed consent 2. Planned to undergone a minimum of 12-months of fixed appliance treatment in both arches 3. Optimal dental health and oral hygiene prior to treatment
Exclusion criteria
Exclusion criteria: 1. Participants who have undergone previous course of fixed appliance treatment 2. Pre-existing clinical evidence of either enamel structural defects, demineralised lesions or fluorosis prior to commencement of treatment 3. Unwilling or unable to give consent 4. Inability to understand written and/or verbal English 5. Vulnerable individuals 6. Participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Age is measured using demographic questionnaire at baseline 2. Gender is measured using demographic questionnaire at baseline 3. Ethnicity is measured using demographic questionnaire at baseline 4. Visible plaque is measured using the Turesky modification of the Quigley–Hein plaque index at baseline, 1 month, 6 months, 12 months and debond 5. Gingival health is measured using the Loe and Silness gingival index at baseline, 1 month, 6 months, 12 months and debond 6. Intra-oral condition is measured using high-quality intra-oral photographs at baseline and debond 7. Supragingival plaque is measured using plaque sampling at baseline, 1 month, 6 months and 12 months 8. Alpha diversity of oral microbiome is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 9. Beta diversity of oral microbiome is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 10. Differential abundance of oral taxa is measured using 16S rRNA gene amplicon sequencing at baseline, 1 month, 6 months and 12 months 11. Functional acidogenicity is measured using standardised glucose challenge with pH recording at 0, 5, 10, 15 and 20 minutes at baseline, 1 month, 6 months and 12 months 12. Resting salivary pH is measured using titration or validated chairside kit score at baseline, 1 month, 6 months and 12 months 13. Salivary buffering capacity is measured using titration or validated chairside kit score at baseline, 1 month, 6 months and 12 months 14. Site-specific acidogenicity effects are measured using three-level mixed models at baseline, 1 month, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactAma Johal
Outcome results
None listed