Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-03 @ 8:50 AM
Study NCT ID:
NCT03068533
Status:
UNKNOWN
Last Update Posted:
2018-02-14
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
The Use of 8% L-Arginine/Calcium Carbonate Containing Toothpaste in Comparison to Strontium Acetate Containing Toothpaste in Management of Hypersensitive Dentine in Chronic Periodontitis Patients : A Randomized-controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dentinal hypersensitivity \[DH\] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for dentin hypersensitivity has been established Thus there is a need to evaluate new formulations in different settings and in different populations and to compare those to commonly used agents seeking better results in pain relief for our patients. Studies showed that dentifrice formulations containing 8% arginine in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules, by clumping of both arginine and calcium carbonate that bind with the negatively charged dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine, calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing 8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.
Detailed Description:
1. Each eligible patient will be given a number.
2. All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
3. The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
4. Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
5. Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
6. Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.
2. All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
3. The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
4. Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
5. Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
6. Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: