Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial)

Cocate, Paula Guedes; Kac, Gilberto; Heitmann, Berit Lilienthal; Nadanovsky, Paulo; Carvalho, Maria Cláudia da Veiga Soares; Benaim, Camila; Schlüssel, Michael Maia; Castro, Maria Beatriz Trindade de; Alves-Santos, Nadya Helena; Baptista, Amanda Farnum; Holick, Michael F.; Mokhtar, Rana; Bomfim, Alessandra Raymundo; Adegboye, Amanda Rodrigues Amorim

doi:10.1186/s40814-019-0417-6

Cited by 13 publications

(16 citation statements)

References 54 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The study protocol has been fully described elsewhere [13]. Briefly, a 2 × 2 factorial feasibility randomised controlled trial employed four intervention groups (without cross-over).…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Adegboye

Cocate

Benaim³

et al. 2020

Trials

Self Cite

View full text Add to dashboard Cite

Background: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol-and setting-related factors related to women's ineligibility and refusal to participate in the study. Methods: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. Results: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Nonparticipation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study. Conclusion: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings. Trial registration: ClinicalTrials.gov, NCT03148483. Registered on 11 May 2017.

show abstract

“…The study protocol has been fully described elsewhere [13]. Briefly, a 2 × 2 factorial feasibility randomised controlled trial employed four intervention groups (without cross-over).…”

Section: Methodsmentioning

confidence: 99%

“…Two study sites in Duque de Caxias in Rio de Janeiro State, Brazil were initially selected for this feasibility trial. However, recruitment was conducted in one site in the Municipal Health Centre of Duque de Caxias [13]. The reasons for including only one site are presented in the "Results" section.…”

Section: Settingmentioning

confidence: 99%

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Adegboye

Cocate

Benaim³

et al. 2020

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

“…The study protocol has been fully described elsewhere (13). Briefly, a 2x2 factorial feasibility randomised controlled trial employed four intervention groups (without cross-over).…”

Section: Methodsmentioning

confidence: 99%

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Adegboye

Cocate

Benaim

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

Background: There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aim of this study is to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy (PT) and describe the patient-, study protocol-and setting-related factors related to women's ineligibility and refusal to participate in the study.Methods: A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2x2 factorial feasibility clinical trial were used. 18 women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions and data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies.Results: Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (>20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patientrelated barriers (e.g. transportation barriers, family obligations, unresponsive to phone calls, and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthy and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation cost) could hinder participation in the study.Conclusion: Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to 3 significant patient-related socio-demographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resourcelimited settings.

show abstract

“…Хронический генерализованный пародонтит присущ более возрастным пациентам -36-55 лет, то гда как практически 98 % пациентов старше 55 лет имеют хронический генерализованный пародонтит тяжелой степени. В свою очередь, встречаемость хронических пародонтитов у пациентов до 55 лет в зависимости от степени тяжести можно распределить в процентном соотношении: хронический генерализованный пародонтит легкой степени -у 21 %; средней степени -у 38,5 %; тяжелой степени -у 40,5 % [9,58]. Такие показатели распространенности заболеваний пародонта свидетельствуют не только о высоком уровне заболеваемости, но и о значительном снижении возраста пациентов, страдающих этой патологией [10,19].…”

Section: Clinical Medicineunclassified

Modern view on integrated treatment of patients with chronic localized periodontitis of medium severity (a literature review)

Синев

Игоревич²,

Nesterov

et al. 2020

Aspirantskiy Vestnik Povolzhiya

View full text Add to dashboard Cite

show abstract

Calcium and vitamin D supplementation and/or periodontal therapy in the treatment of periodontitis among Brazilian pregnant women: protocol of a feasibility randomised controlled trial (the IMPROVE trial)

Cited by 13 publications

References 54 publications

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial

Modern view on integrated treatment of patients with chronic localized periodontitis of medium severity (a literature review)

Contact Info

Product

Resources

About