NCT01549587: OHMOM

A Randomized Controlled Clinical Trial to Evaluate Late First to Mid-Second Trimester Introduction of Advanced Daily Oral Hygiene on Gingivitis and Maternity Outcomes

Completed NA Results posted Last updated 20 April 2023

What this trial tests

NA trial testing 0.243% sodium fluoride in Gingivitis in 746 participants. Completed in 1 April 2014.

Timeline

1 February 2012

Primary endpoint
1 February 2014

1 April 2014

Quick facts

Lead sponsor	Procter and Gamble
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	746
Start date	1 February 2012
Primary completion	1 February 2014
Estimated completion	1 April 2014
Sites	2 locations across United States

Drugs / interventions tested

• 0.243% sodium fluoride — full drug profile →
• toothbrush
• dental floss
• 0.454% stannous fluoride — full drug profile →
• toothbrush
• 0.07% Cetylpyridinium chloride — full drug profile →
• dental floss

Conditions studied

• Gingivitis — all drugs for Gingivitis →
• Pregnancy — all drugs for Pregnancy →

Sponsor

Procter and Gamble — full company profile →

Who can join

18 and older, female only, with Gingivitis or Pregnancy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in Löe-Silness Gingivitis Index
  Time frame: 3 months
  Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
• Change From Baseline in Löe-Silness Gingivitis Index
  Time frame: 2 months
  Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.
• Change From Baseline in Löe-Silness Gingivitis Index
  Time frame: 1 month
  Score Criteria 0 Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema, and glazing. Bleeding on probing. 3. Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treating periodontal disease for preventing adverse birth outcomes in pregnant women.
   Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. · · 2017 · cited 110× · PMID 28605006 · DOI 10.1002/14651858.cd005297.pub3
2. Association between Maternal Periodontitis and Development of Systematic Diseases in Offspring.
   Starzyńska A, Wychowański P, Nowak M, Sobocki BK, et al · · 2022 · cited 17× · PMID 35269617 · DOI 10.3390/ijms23052473