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8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin

Primary Purpose

Dentin Hypersensitivity

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
8% L-Arginine/calcium carbonate containing toothpaste
use of strontium acetate toothpaste
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Hypersensitivity focused on measuring DH, dentin hypersensitivity, chronic periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.

  2. 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)
  3. Provision of written informed consent

Exclusion Criteria:

  1. Chipped teeth.
  2. Defective restorations.
  3. Deep dental caries or large restorations showing pulpal response.
  4. Ongoing treatment with anti-inflammatory drugs.
  5. Ongoing treatment for tooth hypersensitivity.
  6. Pregnancy.
  7. Uncontrolled metabolic diseases.
  8. Psychiatric disorder.
  9. Smoking

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Strontium acetate toothpaste

Arginine/calcium carbonate toothpaste

Arm Description

All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.

All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Probing pocket depth
probing depth from gingival margin and till base of the pocket or sulcus in mm.
Gingival recession (GR)
if present, distance between gingival margin to cemento-enamel junction in mm.

Full Information

First Posted
February 22, 2017
Last Updated
February 13, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03068533
Brief Title
8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 3, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Each eligible patient will be given a number. All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation. The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement. 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). 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. Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Hypersensitivity
Keywords
DH, dentin hypersensitivity, chronic periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strontium acetate toothpaste
Arm Type
Active Comparator
Arm Description
All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
Arm Title
Arginine/calcium carbonate toothpaste
Arm Type
Experimental
Arm Description
All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
Intervention Type
Other
Intervention Name(s)
8% L-Arginine/calcium carbonate containing toothpaste
Intervention Description
use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity
Intervention Type
Other
Intervention Name(s)
use of strontium acetate toothpaste
Intervention Description
use of strontium acetate toothpaste to relieve hypersensitivity
Primary Outcome Measure Information:
Title
change from baseline Pain (sensetivity) at 8 weeks
Description
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)
Time Frame
baseline and after 8 weeks
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
probing depth from gingival margin and till base of the pocket or sulcus in mm.
Time Frame
baseline and after 8 weeks
Title
Gingival recession (GR)
Description
if present, distance between gingival margin to cemento-enamel junction in mm.
Time Frame
baseline and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Chipped teeth. Defective restorations. Deep dental caries or large restorations showing pulpal response. Ongoing treatment with anti-inflammatory drugs. Ongoing treatment for tooth hypersensitivity. Pregnancy. Uncontrolled metabolic diseases. Psychiatric disorder. Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof.Dr. Manal Hosni
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin

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