Dental Support Device During Breastfeeding as a Mean for Pain Control
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ClinicalTrials.gov Identifier: NCT02639663 |
Recruitment Status : Unknown
Verified December 2015 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
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Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Condition or disease | Intervention/treatment | Phase |
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Breastfeeding | Device: dental device | Phase 3 |
Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 700 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dental Support Device During Breastfeeding as a Mean for Pain Control |
Study Start Date : | January 2016 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | January 2018 |

Arm | Intervention/treatment |
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Experimental: women whom are interested in breastfeeding and have not begun.
Post-partum primi and multiparous women Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
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Device: dental device
Leboride
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Experimental: Post-partum women that have already begun breast feeding
2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device.
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Device: dental device
Leboride
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- Rate of change in of the vas scores before and after using this device [ Time Frame: 24 months ]
- Duration of breastfeeding [ Time Frame: 24 months ]
- The rate of cessation of breastfeeding because of pain [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Maternal age 18-45 years. Normal vital signs.
Exclusion Criteria:
Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639663
Contact: Ariel many, professor | 052-4266954 | arielm@tlvmc.gov.il |
Principal Investigator: | Ariel many, professor | Tel Aviv Medical Center |
Responsible Party: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT02639663 |
Other Study ID Numbers: |
559-15-TLV |
First Posted: | December 24, 2015 Key Record Dates |
Last Update Posted: | December 24, 2015 |
Last Verified: | December 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |