To evaluate and compare the efficacy and safety of neutral oral cream to heal mucosal wound against placebo on healthy subjects over a 14 day period of home use.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001242

Enrollment

Registered

2010-09-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Oral wound healing (clinical and size of wound)- Neutral oral Cream with ZnCl2 (active) with antioxidants: Topical Application, twice daily for 14 days. Control Intervention1: Neutral O

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to understand and sign a consent form prior to the recruitment on the study. 2. Male subjects 18 -30 years old 3. Minimum 24, non restored natural teeth. 5. Good general and oral health 6. Ability and willingness of subjects to follow the study procedures attend all scheduled visits and successfully complete the study

Exclusion criteria

Exclusion criteria: 1. Compromise Medical Conditions (History of any bleeding disorder/ diabetes/ hepatitis/ hypertension/ anemia) 2. Systemic ailments or on- going medicaments 3. Mouth wash users 4. Periodontitis/ gum recession/ ulcers/ any other oral soft tissue lesions 5. Active caries 6. Smokers and compulsive tobacco chewers 7. Orthodontic appliances/ dentures 8. Any known allergy (any dental or oral hygiene products) 9. Use of antibiotics/ anti-inflammatory 15 days prior to the enrollment of the subject to the study 10. Participating in any other trials

Design outcomes

Primary

Measure	Time frame
Initial wound area compared to wound area after 14 days home use.Timepoint: 14 Days	—

Secondary

Measure	Time frame
Initial Scores of clinical wound healing parameter (redness, swelling,sloughing, start of keratinization) compared to scores after 14 days home useTimepoint: 14 days	—

Countries

India

Contacts

Public ContactRagi Menon

ragi@smilecareindia.com91 22 26431670

Outcome results