Condition 1: Dental plaque. Condition 2: Gingivitis. Deposits [accretions] on teeth Acute gingivitis, plaque induced
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Having at least 22 natural teeth, including all anterior maxillary teeth in sextant 2 , with two evaluable surfaces (buccal and lingual) Absence of orthodontic appliances or retainer devices No presence of any type of intraoral prosthesis (including removable prostheses or ill-fitting fixed restorations that may increase plaque accumulation) No systemic diseases affecting gingival inflammation (e.g., diabetes, hypertension, etc.) No history of medical or pharmaceutical interventions (e.g., use of antibiotics, anti-inflammatory drugs, or hormonal medications) that may interfere with the study during the past 3 months No use of mouthwash, gel, or chewing gum containing antimicrobial agents in the past 3 months Not pregnant or breastfeeding No presence of any form of periodontal disease
Exclusion criteria
Exclusion criteria: Known allergy or hypersensitivity to ingredients in Ultranamel spray or Chlorhexidine mouthwash Use of tobacco products (cigarettes, hookah) or alcohol Presence of cognitive or psychological disorders impairing compliance with study instructions Participation in other interventional studies within the past 3 months Inability to attend regular follow-up visits during the study period Severe speech or motor disorders that interfere with proper oral hygiene practices Extensive dental caries or defective restorations that may compromise accurate assessment of plaque or gingival indices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dental plaque score measured using the Turesky modification of the Quigley-Hein plaque index, which quantifies visible plaque coverage on the tooth surfaces. Scores range from 0 (no visible plaque) to 5 (entire surface covered with thick plaque). The mean score is calculated based on buccal and lingual surfaces of all teeth examined. Timepoint: Plaque index will be measured at baseline (prior to intervention), at the end of each intervention phase (day 7 of each period), and after the washout period. Method of measurement: Plaque is disclosed using a disclosing agent and scored on the buccal and lingual surfaces using the Turesky modification of the Quigley-Hein index by a calibrated dentist under clinical conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gingival inflammation score assessed using the Silness and Loe Gingival Index, which evaluates gingival condition based on color, swelling, and bleeding upon probing. Four sites per tooth (mesial, distal, buccal, and lingual) are examined, and their average is calculated for each tooth. The overall gingival index is the mean score of all examined teeth. Scores range from 0 (no inflammation) to 3 (severe inflammation with spontaneous bleeding). Timepoint: Gingival index measurements will be taken at baseline (prior to intervention), at the end of each intervention phase (day 7 of each period), and after the washout period. Method of measurement: Gingival index is measured using the Silness and Loe method with a periodontal probe, through clinical observation by a calibrated dentist, evaluating four surfaces of each tooth in a standard clinical setting. | — |
Countries
Iran (Islamic Republic of)
Contacts
Qazvin University of Medical Sciences