Antiplaque/Antigingivitis Effect of Lacer Oros Integral
Launched by UNIVERSIDAD COMPLUTENSE DE MADRID · May 5, 2021
Trial Information
Current as of August 15, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 35-64 years old.
- • Periodontitis patients, already enrolled in a SPT, for at least 6 months, and the last SPT visit in the previous 6 months.
- • Systemically healthy, following the criteria of the American Society of Anesthesiologists (ASA), for patients ASA type I or II (see also exclusion criteria).
- • Presence of at least three evaluable teeth in each quadrant.
- • Moderate gingival inflammation (≥40% bleeding on marginal probing, BOMP) (Van der Weijden, Timmerman, Nijboer, Reijerse, \& Van der Velden, 1994) and Turesky plaque index ≥1.5. Also 2017 World Workshop criteria and bleeding on probing (BOP) (Ainamo \& Bay, 1975) criteria will be considered. The primary criteria will be BOP ≥30% and Turesky plaque index ≥1.5
- • No orthodontic banding or removable prosthesis.
- • Subjects willing to participate and comply with the requirements of the study.
- • Complains of dentin hypersensitivity in, at least, one evaluable tooth. Dentin hypersensitivity will be confirmed with evaporative sensitivity (Schiff et al., 1994), with a minimum score of 2-3 (West et al., 2013), although a score of 1 will also be considered as adequate. In order to be eligible, the selected tooth must not have a current desensitizing therapy, must not have been restored in the last 3 moths, or have a crown or a big restoration. Only incisors, canines and premolars will be considered (Holland, Narhi, Addy, Gangarosa, \& Orchardson, 1997).
- Exclusion Criteria:
- • Untreated or uncontrolled periodontitis
- • Regular use of antiseptic-containing and/or anti-hypersensitivity mouth rinses.
- • Antibiotic intake within the previous month.
- • Excessive exposure to acids (eating disorders, chronic regurgitation).
- • Chronic use of analgesic or anti-inflammatory drugs.
- • Pregnant women.
- • Any adverse medical history (diabetes, osteoporosis, immunosuppression...) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
- • Conditions which requires antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis...).
About Universidad Complutense De Madrid
The Universidad Complutense de Madrid (UCM) is a prestigious academic institution renowned for its commitment to research and innovation in various fields, including health sciences. As a prominent sponsor of clinical trials, UCM leverages its extensive resources and expertise to advance medical knowledge and improve patient outcomes. The university fosters collaboration among researchers, clinicians, and industry partners, ensuring the highest standards of ethics and scientific rigor in its clinical research initiatives. UCM's dedication to education and research excellence positions it as a leader in the development of new therapeutic interventions and health solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Patients applied
Trial Officials
David Herrera, Prof
Principal Investigator
University Complutense
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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