Recruitment, consent, retention and sample size
A convenience sample of twenty-five mothers who met the inclusion criteria were recruited over a three week period. All of the mothers were three months into their pregnancy. This represented 10% of all of the women who attended the clinic over the 3 month period. All the women provided informed and written consent. The women were aged between 16 and 35 years old. Of the 25 mothers, 14 attended the appointment at Time 1 and 22 attended at Time 2. This gave an overall retention rate between baseline and Time 1 of 56% and between baseline and Time 2 of 88%. Four members of the nursing and administrative staff fulfilled the eligibility criteria and were invited to take part. All provided informed and written consent.
The decision to proceed to the full trial depended on ADePT evaluation outcome (Table 2). It explored the evidence from the feasibility study and potential methodological issues of future full trial, as follows:
Sample size calculation and eligibility and consent of participants
Table 2 provides the details of the sample size calculation which indicated a total sample size of 400 participants for a full trial, together with details of eligibility and consent to participate.
Process evaluation: adherence and acceptability of the intervention
Interviews were conducted with five women who attended at baseline and Time 2 appointments but had not attended the Time 1 appointment. From the remaining 17 women who attended all three appointments, five women were randomly chosen and invited to take part (Table 2).
All of the women interviewed stated they enjoyed TIPPS, found the TIPPS intervention helpful and liked the information and support on how to brush their teeth correctly. They were also very grateful for the supply of toothbrushes and fluoride toothpaste free of charge - as one woman commented, ‘It is so important that you gave us the toothpaste and toothbrush, this is why we can brush our teeth’. Many of the women commented that they had never been shown how to brush their teeth before and a consequence of the TIPPS programme was not only to train them how to brush their teeth effectively, ‘My teeth are crowded, the interdental brush really helps me to clean between them’, but also enabled them to take the TIPPS message home to help children brush their teeth. As one woman stated, ‘I’ve taught my sons how to brush their teeth now, after learning about it here’.
When asked about additional thoughts on the programme, they stated that the TIPPS programme should be part of the antenatal programme throughout pregnancy and that dental treatment should also be part of the intervention, with a facility to remove calculus and restore teeth. For the women who had not attended the first follow-up appointment (Time 1), the reasons for non-attendance were associated with family constraints and difficulties experienced in travelling to the clinic. These women felt strongly that while they saw the benefit of the TIPPS intervention, they would only attend if the appointments were at the same time and part of their antenatal appointment.
Five people from the clinical and administrative staff agreed to be interviewed. The nurses agreed with the opinions voiced by the women that the TIPPS intervention in general was an excellent idea and they enjoyed learning about TIPPS and having the opportunity to implement it with the pregnant women. They appreciated the need for goal setting and while time consuming, some believed that it was important, ‘because the life style and culture of people, their ways of tooth brushing and background about oral health importance differ from one area to another’. Some nurses and staff also stated that they believed in the importance of the programme and felt that for the TIPPS intervention to be widely appreciated it should, ‘involve many different areas - this would make it more representative and results generalizable’. Despite this, they felt that they were too busy to recruit women into the programme and to provide the TIPPS intervention in already understaffed and busy clinics. A commonly voiced concern was that they felt they were too ill-informed to answer any other dental questions other than about gum health, tooth brushing and interdental cleaning. They felt that a dentist should be employed for that purpose. A dental surgery should be provided at the clinic where the TIPPS intervention would be implemented and dental treatment provided by a dental team.
Potential risks to the successful implementation of TIPPS included the lack of engagement of some pregnant women to attend any appointments, the potential costs of toothbrushes, toothpaste and interdental cleaning being unaffordable for the women and the costs to the clinic; the increased healthcare personnel costs were mentioned by the nurses and others. The following quotes are illustrative:
‘There are mothers who do not collaborate with the dentist or nurse, do not return for their appointments and would not follow the instructions for taking care of their teeth. I believe these mothers are in need of more intensive oral health education lessons.’
‘The cost should be considered. Is it going to be frequently available or is it going to be available only for [high risk] groups? The budget [for the programme] needs to be high for staff time and resources. . . [the] antenatal care programme is already free of charge and if you ask a mother to buy toothpaste and brush, she may not be able to afford the cost.’
Thinking to the future, the head of antinatal care stated that she felt that the TIPPS programme could experience difficulties, especially when violence had resulted in a previous dental treatment service being removed from the clinic, ‘after the increase in political instability this programme was stopped’. Concerns were raised with regard to the disruption of an already busy clinic, especially if the pregnant woman failed to attend or arrived late or on another day for their appointment, and the additional effect of TIPPS on an already busy clinic. The division of healthcare into definite disciplines was also voiced, ‘highly skilled midwives involved in oral health care and education to run a programme which previously had dentists responsible for this work.’
Intervention costs and duration
The total costs for the provision of toothbrushes, toothpastes and interdental cleaning aids, together with the costs of the TIPPS information materials for the training day and for the participating pregnant women were known. No economic evaluation was undertaken.
Completion of the outcome assessments: quality of the data
At baseline there was no missing data for the primary and secondary outcome variables. Twelve percent of the secondary outcome variables were missing at Time 2, and 22% of the primary outcome variable was missing when collected from the mothers on the delivery of their babies (Table 2).
Appropriateness of the outcomes measured
Three of the women were prima gravida; one woman had had a miscarriage. For the remaining 21 mothers, they had between 2 to 7 pregnancies and had between 1 and 5 surviving children. For the 21 mothers, the mean birth-weight of their last infant was 3.25 (SD 0.46) kgs with a range of 2.5-4.0 kgs. Twenty-two mothers were contacted following the birth of their babies. The mean birth-weight of their new infants for women with more than one previous pregnancy was 3.12 (SD 0.30) kgs with a range of 2.5-3.6 kgs (Table 2). Of the remaining three women who were prima gravida, two were contactable. One woman had twins, one of whom died and the other born prematurely at 0.75 kgs (now a healthy baby), and the mean weight of the infant of the other first time mother was 2.50 kgs.
Figure 1 shows the changes in mean percentage plaque and bleeding scores over time. There were statistically significant differences in mean rank percentage plaque scores from baseline to Time 2, for the upper teeth (X2 [2] =21.51: P<0.001) and lower teeth (X2[2] =18.31P<0.001) across the three time points. There were also statistically significant differences in mean rank percentage bleeding scores from baseline to Time 2, for upper teeth (X2 [2]=25.24:P<0.001), and lower teeth (X2[2]=22.91: P<0.001) across the three time points.
Logistics of running the feasibility study in LMIC in an area of conflict
Recruitment of the pregnant women and clinic staff went well due to XX’s specialist knowledge, interactions with clinic staff and support from the head of the clinic. However, difficulties transporting dental supplies from the UK to Gaza city were experienced. The toothbrushes, toothpastes and examination kits were only able to be released from customs (Table 2) following the intervention of the Chief Dental Officers from Palestine and Israel.
Synergy between all components of the protocol
All of the elements of the study worked well together. The findings of the study increased our knowledge and the need for a dedicated place for the TIPPS intervention, where women would be happy to discuss their oral health problems and have trained oral health staff to provide the TIPPS intervention (Table 2).