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Abstract The success rate of restorations reported in the present study was similar to that of other studies reporting 100% success rates among pregnant women with chemo- mechanical caries removal agents and 97.6% with ART [39]. The relatively lower success rate in the present study may be attributed to loss to follow up and assigning the worst score to lost cases based on the intention-to-treat analysis. Restoration success had significant impact on OHRQoL improvement in the present study. This indicates that the impact on OHRQoL is mainly related to the effectiveness of the restoration and not just an effect attributed to receiving the treatment regardless of its success. The present study revealed that besides being effective in caries treatment, Papacarie-Duo had greater impact on OHRQoL of expectant mothers with mild to moderate dental pain. It is important to include patient-reported outcome measures in clinical trials besides clinical and dentist-assessed measures. OHRQoL measures capture the impact of treatment from patients’ perspectives and this is critical for interventions addressing oral health problems that are partly perpetuated by patient behavior or misconceptions such as in the present study. One of the limitations of this study is related to the short time frame of pregnancy which did not allow a longer follow-up period. There might have been a tendency to report lower impact of oral health because of social desirability bias. In addition, patients with poor oral health and poor expectation may not consider themselves to have poor OHRQoL and consequently report lower scores on OHIP-14. The findings apply to pregnant women and to occlusal caries. In other population groups or types of caries, the findings may not apply and further studies are needed to study these differences. Future studies are needed with larger sample size and longer follow-up periods to assess the long-term effect of minimal invasive caries removal methods. Papacarie-Duo does not require extensive training for dental health care professionals to be able to use it and does not need sophisticated equipment. It is recommended to integrate this caries removal method as a part of the WHO proposed Basic Package of Oral Care [44] which includes pain relief, preventive, promotional and atraumatic restorative treatments for pregnant women in primary health centers in low- and middle- income countries. Integrating this package with their routine antenatal health care may have great benefits for their oral health and needs to be addressed in future research to help in the control and prevention of dental caries. |