Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04881357
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…).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
64 Years
Study:
NCT04881357
Study Brief:
Protocol Section:
NCT04881357