Status:
COMPLETED
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Lacer S.A.
Conditions:
Periodontitis
Dental Plaque
Eligibility:
All Genders
35-64 years
Phase:
NA
Brief Summary
Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona, Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride, dipotassium g...
Eligibility Criteria
Inclusion
- 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
- 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…).
Key Trial Info
Start Date :
September 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04881357
Start Date
September 4 2021
End Date
July 10 2022
Last Update
July 25 2023
Active Locations (1)
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1
Faculty of Dentistry, Univesity Complutense, Madrid
Madrid, Spain, 28040