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Search / Trial NCT04881357

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.

Locations

Madrid, , Spain

Patients applied

0 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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