Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Recruitment rates - feasibility criteria |
Data on ability to recruit randomise 84 participants to target in a 7-month recruitment window. Green =80%. Amber 60-79%. Red =59%. |
7 months |
|
Primary |
Visiting data - feasibility criteria |
Percentage of participants with available data on dental visiting via self-report or BSA data. Green =90%. Amber 60-89%. Red =59%. |
9 months |
|
Primary |
Clinical exam - feasibility criteria |
Percentage of participants completing the dental examination. Green =80%. Amber 60-79%. Red: =59%. |
9 months |
|
Primary |
Adherence to intervention - feasibility criteria |
Percentage of participants receiving intervention =1 sessions during nine month window. Green =80%. Amber 60-79%. Red =59%. |
9 months |
|
Primary |
Intervention and trial protocol - feasibility criteria |
Qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. This will be via qualitative interviews with service users (participants), research staff (link workers, research assistants), and key stakeholders (referrers, managers, commissioners). Audio recordings of sessions and field notes will also be analysed. |
9 months |
|
Primary |
Safety of intervention - feasibility criteria |
Monitoring and review of research related serious adverse events (SAEs). The Trial Steering Committee (TSC) will oversee SAEs across treatment arms. The authors will discontinue the trial if the intervention or procedures elevate risk. |
9 Months |
|
Secondary |
Brief Pain Inventory - short form |
A questionnaire to assess orofacial pain. |
Baseline and 9 month assessments |
|
Secondary |
Manchester Orofacial Pain Disability Scale |
Pain related disability |
Baseline and 9 month assessments |
|
Secondary |
Oral Health Impact Profile |
Oral health related quality of life |
Baseline and 9 month assessments |
|
Secondary |
Confidence around dental visiting |
Item asking about confidence in visiting the dentist. "How confident are you that you will be able to attend a dental appointment?" (1, no confident; 7, very confident) |
Baseline and 9 month assessments |
|
Secondary |
Rosenberg Self-esteem Scale (RSES) |
Assessing self-esteem |
Baseline and 9 month assessments |
|
Secondary |
Modified Dental Anxiety Scale |
Assessing dental anxiety |
Baseline and 9 month assessments |
|
Secondary |
Patient Health Questionnaire (PHQ) |
Assessing depression |
Baseline and 9 month assessments |
|
Secondary |
EuroQol 5 Dimension (EQ-5D-5L) |
Assessing quality of life |
Baseline and 9 month assessments |
|
Secondary |
The number of eligible participants able to access free or subsidised dental care |
Assessing ability to successfully access free or subsidised dental care collected via the business services authority and self-report. |
Baseline and 9 month assessments |
|
Secondary |
The number of planned dental appointments attended |
The research team will record and report the number of routine dental appointments attended, recorded by both the business services authority and self-report. |
Baseline and 9 month assessments |
|
Secondary |
Oral health self-management - tooth brushing, mouth wash, and flossing |
'How often do you brush your teeth nowadays?' (ordinal five-point scale); 'How long do you brush your teeth for nowadays?' (ordinal five-point scale); 'How often do you clean between your teeth (inter-dental cleaning with floss, inter-dental brushes, tooth picks)?' (ordinal five-point scale); and 'Do you use a fluoride mouth-wash?' (binary) |
Baseline and 9 month assessments |
|
Secondary |
Self reported attendance at a planned dental appointment |
The research team will ask people the following 'Have you attended a dental service since the baseline assessment (nine months ago)? This would include a routine appointment with a dentist or special care dentistry service. It could also include a planned appointment at a dental hospital. However, it would not include an emergency dental appointment.'. Participants will also be asked to provide the dates and times of dental appointments. This outcome will be coded as whether the person has or has not accessed a planned dental appointment via self-report. |
9 months |
|
Secondary |
Business services authority recorded attendance at a planned dental appointment |
NHS England collects information on visiting behaviour via the Business Services Authority. The research team will gain participants consent to extract this data, which the researchers will then match to the participants research data. The business services authority will be used to collect data on whether a planned care appointment has taken place. This data will only pick up National Health Service, and not private, dental appointments. This outcome will be coded as whether the person has or has not accessed a planned dental appointment via the business services authority data. |
9 months |
|
Secondary |
Number of decayed, missing, or filled teeth (DMFT) via dental examination |
An examination for dental caries in permanent teeth will involve examining 32 teeth (i.e. all permanent teeth including wisdom teeth) with a metallic periodontal probe (Community Periodontal Index (CPI) probe) and a plane mouth mirror. |
Baseline and 9 months |
|
Secondary |
Pulpal involvement, ulceration due to trauma, fistula, and abscess (PUFA) via dental examination |
The PUFA score per person is calculated in the same cumulative way as for the DMFT and represents the number of teeth that meet the PUFA diagnostic criteria. Thus, for an adult in our study the score can range from 0 to 32 PUFA. |
Baseline and 9 months |
|
Secondary |
Modified Plaque Score via dental examination |
The locally derived system involves assessing six teeth representative of the entire dentition, for the worst plaque score on each tooth surface from visual examination and, where necessary, the use of a probe to detect the presence of plaque. These six teeth are the UL4 UL1 UR6 LL6 LR1 LR4. Each surface; Interproximal, buccal and lingual or palatal of the six teeth should be viewed in turn and the highest level of visible plaque on each surface should be scored '2'. |
Baseline and 9 months |
|