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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dentin Hypersensitivity
• Intervention / Treatment: Other: use of strontium acetate toothpaste; Other: 8% L-Arginine/calcium carbonate containing toothpaste

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Strontium acetate toothpaste; All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.	Other: use of strontium acetate toothpaste; use of strontium acetate toothpaste to relieve hypersensitivity
Experimental: Arginine/calcium carbonate toothpaste; All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.	Other: 8% L-Arginine/calcium carbonate containing toothpaste; use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Prof.Dr. Manal Hosni, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): March 3, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: DH, dentin hypersensitivity, chronic periodontitis
• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Periodontitis; Hypersensitivity; Dentin Sensitivity; Chronic Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: Abdallah Hassan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No