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.
- Registration Number
- CTRI/2010/091/001242
- Lead Sponsor
- Smilecare Clinic Pvt. Ltd.13, Geetanjali, 234, S. V. Road, Bandra (W), Mumbai- 400 050
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Initial wound area compared to wound area after 14 days home use.Timepoint: 14 Days
- Secondary Outcome Measures
Name Time Method Initial Scores of clinical wound healing parameter (redness, swelling,sloughing, start of keratinization) compared to scores after 14 days home useTimepoint: 14 days