Skip to content

: Comparison of the effect of Ultranamel spray and Chlorhexidine mouthwash on dental plaque and gingival inflammation in students of Qazvin university of medical science

A randomized, triple-crossover, double-blind clinical trial comparing the effectiveness of Ultranamel oral spray and Chlorhexidine mouthwash in controlling dental plaque and gingival inflammation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240229061133N1
Enrollment
30
Registered
2025-12-01
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Dental plaque. Condition 2: Gingivitis. Deposits [accretions] on teeth Acute gingivitis, plaque induced

Interventions

Intervention 1: Control group: Participants in this group will use only routine tooth brushing (twice daily for 2 minutes) with a standard fluoride toothpaste. No mouthwash or oral spray will be used.

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

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

MeasureTime 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

MeasureTime 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

Public ContactMaryam Amini Dehaghi

Qazvin University of Medical Sciences

maryam.aminiii02@gmail.com+98 28 3335 3061

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026