Status:

COMPLETED

Impact of a Newly Formulated Toothpaste in Tooth Staining Associated With Chlorhexidine Rinses

Lead Sponsor:

Universidad Complutense de Madrid

Collaborating Sponsors:

Dentaid SL

Conditions:

Tooth Staining

Periodontitis

Eligibility:

All Genders

30-69 years

Phase:

NA

Brief Summary

Dental staining may interfere with compliance with chlorhexidine mouth rinse use Thus, developing strategies to control tooth staining associated with chlorhexidine use may be relevant for improving ...

Detailed Description

The primary objective of these RCTs will be to evaluate the capacity of preventing tooth staining, associated with the use of a chlorhexidine mouth rinse, adjunctive to subgingival instrumentation (st...

Eligibility Criteria

Inclusion

  • 30-69 years old.
  • Periodontitis patients, in stages I-III, requiring steps 1 and 2 of periodontal treatment including full-mouth subgingival instrumentation.
  • 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.
  • No orthodontic banding or removable prosthesis.
  • Subjects willing to participate and comply with the requirements of the study.

Exclusion

  • Acute periodontal conditions.
  • Antibiotic intake within the previous month.
  • 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 require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).

Key Trial Info

Start Date :

October 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2024

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT05354986

Start Date

October 1 2022

End Date

January 31 2024

Last Update

May 9 2024

Active Locations (1)

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Faculty of Dentistry, University Complutense of Madrid (UCM)

Madrid, Spain, 28040