Evidence map›Paper›PMID 41366490›Full record

ArticleTrials2025

Oral health care during pregnancy to prevent preterm birth and low birth weight: study protocol for a randomized controlled trial.

Junko Yasuoka, Yohei Takeshita, Shunsuke Okada, Prodhan Md Rubayet Alam, Akira Shibanuma, Keiko Nanishi, Yoko Sato, Md Zahid Hossain, Musfiqa Aman, Fahmida Karim and 7 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Junko YasuokaDivision of Global Health Sciences, Graduate School of Public Health, St. Luke's International University, Tokyo, Japan. yasuoka@slcn.ac.jp.ORCID http://orcid.org/0009-0003-5120-509X
Yohei TakeshitaDepartment of Oral and Maxillofacial Radiology, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Shunsuke OkadaDepartment of Oral and Maxillofacial Radiology, Medical Development Field, Okayama University, Okayama, Japan.
Prodhan Md Rubayet AlamDepartment of Orthodontics, Dental Unit, TMSS Medical College & Rafatullah Community Hospital, Bogura, Bangladesh.
Akira ShibanumaDepartment of Community and Global Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Keiko NanishiOffice of International Academic Affairs, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Yoko SatoDepartment of Health Sciences, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Md Zahid HossainDepartment of Periodontology and Oral Pathology, Holy Family Red Crescent Medical College Hospital, Dhaka, Bangladesh.
Musfiqa AmanDepartment of Periodontology, Dental Unit, TMSS Medical College & Rafatullah Community Hospital, Bogura, Bangladesh.
Fahmida KarimDepartment of Obstetrics & Gynecology, Holy Family Red Crescent Medical College Hospital, Dhaka, Bangladesh.
Sultana RaziaDepartment of Obstetrics & Gynecology, TMSS Medical College & Rafatullah Community Hospital, Bogura, Bangladesh.
Rifat RezwanaDepartment of Molecular and Cellular Biochemistry, Division of Oral Health, Brain Health and Total Health, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.
Md Mahmudur RahmanGlobal Communication Center, Grameen Communications, Dhaka, Bangladesh.
Nusrat Jahan KhanGlobal Communication Center, Grameen Communications, Dhaka, Bangladesh.
Naoki NakashimaDepartment of Medical Informatics, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Rafiqul IslamDivision of Healthcare Digital Transformation, Kyushu University, Fukuoka, Japan.
Kimiyo KikuchiDepartment of Research Promotion, Institute for Asian and Oceanian Studies, Kyushu University, Fukuoka, Japan.

Funding

Japan Society for the Promotion of Science 24K02702
6 · The paper itself

Abstract

backgroundPeriodontal disease during pregnancy has been associated with an increased risk of preterm birth (PTB) and low birth weight (LBW). However, most previous interventional studies have reported that scaling and root planing (SRP), a form of basic periodontal treatment, is insufficient to effectively prevent PTB and LBW. Recent systematic reviews and meta-analyses suggest that combining SRP with routine use of chlorhexidine gluconate (CHG) mouthwash may reduce the risk of these adverse birth outcomes by approximately half. This study will be among the first randomized controlled trials (RCTs) to evaluate the potential synergistic effects of this combined approach on improving birth outcomes.

methodsThis multi-center, three-arm RCT will be conducted at two hospitals in Dhaka and Bogura, Bangladesh, between April 2025 and September 2026. A total of 480 pregnant women less than 20 weeks' gestation attending antenatal checkups will be recruited. Participants diagnosed with periodontal disease will be randomly assigned to either an intervention group or a positive control group. Participants without periodontal disease will be assigned to a negative control group. The intervention consists of SRP combined with continued use of CHG mouthwash throughout pregnancy. The primary outcome will be the rate of PTB. Secondary outcomes include the birth weight of the newborn baby, maternal periodontal status, and oral health-related quality of life (OHRQoL). Effectiveness will be assessed by comparing outcomes across the study groups. DISCUSSION: The oral health intervention is expected to improve both birth outcomes and maternal oral health. Demonstrating its effectiveness in a real-world setting may support the integration of oral health care into broader maternal, neonatal, and child health strategies, particularly in resource-limited settings.

trial registrationUMIN Clinical Trials Registry. UMIN000057519. Registered on April 4, 2025. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000065719 .

Indexed as

Dental ScalingInfant, Low Birth WeightOral HealthPeriodontal DiseasesPregnancy ComplicationsPremature BirthPrenatal CareRoot PlaningBangladeshChlorhexidineFemaleHumansInfant, NewbornMouthwashesMulticenter Studies as TopicPregnancyChlorhexidinechlorhexidine gluconateMouthwashesBangladeshChlorhexidine gluconate mouthwashLow birth weightOral healthPeriodontal treatmentPreterm birthRandomized controlled trial

Identifiers

PMID41366490
PMCPMC12802306

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.