N/A
N=746
Oral Hygiene and Maternity Outcomes Multicenter Study (OHMOM)
Gingivitis · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01549587 ↗Enrolled (actual)
746
Serious AEs
20.6%
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline in Löe-Silness Gingivitis Index — 0.141; 0.154 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.243% sodium fluoride (Drug); toothbrush (Device); dental floss (Device); 0.454% stannous fluoride (Drug); 0.07% Cetylpyridinium chloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Procter and Gamble
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Löe-Silness Gingivitis Index |
0.112; 0.125 | — |
| PRIMARY Change From Baseline in Löe-Silness Gingivitis Index |
0.112; 0.125 | — |
| PRIMARY Change From Baseline in Löe-Silness Gingivitis Index |
0.112; 0.125 | — |
| SECONDARY Gestational Age (Weeks) |
1.3988; 1.3271 | — |
Summary
This study will track changes in oral health in pregnant women. Subjects will be assigned to either regular oral care or advanced oral care and be given oral care products to use until they deliver. A comparison between the two groups (regular and advanced oral care) will be made to see if the oral care products impacted oral health and maternity variables.
Eligibility Criteria
Inclusion Criteria
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- be at least the age of legal consent;
- be between 8 and 24 weeks of pregnancy;
- have at least 20 natural teeth;
- have moderate-to-severe gingivitis during pregnancy, including at least 30 intraoral sites with evidence of marginal gingival bleeding.
Exclusion Criteria
- evidence of multiple gestations;
- history of HIV infection, AIDS, autoimmune disease, or diabetes other than gestational diabetes;
- indication for use of antibiotic pre-medication prior to dental procedures;
- systemic corticosteroid or immunosuppressive therapy within 1 month of Baseline;
- severe periodontal disease, rampant untreated dental caries, or other oral conditions that necessitate immediate dental care;
- ongoing dental care that in the opinion of the investigator could impact study participation;
- a history of allergies or hypersensitivity to mouth rinse products containing CPC;
- any disease or condition that in the opinion of the investigator could interfere with the safe completion of the study;
- randomization to a treatment in study 2011001 during a prior pregnancy.
Data sourced from ClinicalTrials.gov (NCT01549587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.