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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strontium acetate toothpaste | Active Comparator | All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. |
|
| Arginine/calcium carbonate toothpaste | Experimental | All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8% L-Arginine/calcium carbonate containing toothpaste | Other | use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline Pain (sensetivity) at 8 weeks | This will be assessed using VAS that will be determined immediately before product use and then after 8 weeks of daily brushing with the test and control toothpastes following stimulus application using Visual Analog Scale (VAS) | baseline and after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | probing depth from gingival margin and till base of the pocket or sulcus in mm. | baseline and after 8 weeks |
| Gingival recession (GR) | if present, distance between gingival margin to cemento-enamel junction in mm. |
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Inclusion Criteria:
Slight to moderate chronic periodontitis patients diagnosed according to criteria of (Parameter on chronic periodontitis with slight to moderate loss of periodontal support.
American Academy of Periodontology., 2000) as follows : Probing pocket depths up to 6mm Clinical attachment loss (CAL) up to 4mm Class I (incipient) furcation involvement Radiographic evidence of bone loss.
At least 2 teeth presenting hypersensitive areas on facial surfaces of teeth with score 2 or 3 on the air sensitivity scale (Pepelassi et al., 2015)
Provision of written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr. Manal Hosni | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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similar empty tubes filled by the control and intervention toothpaste then sealed and given a number only.The patients,care provider,outcome assessor and investigator are blinded to the intervention and control toothpaste.
| use of strontium acetate toothpaste | Other | use of strontium acetate toothpaste to relieve hypersensitivity |
|
| baseline and after 8 weeks |
| D009059 |
| Mouth Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000601 | Amino Acids, Essential |