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

NCT03068533 | Unknown

• 1 other identifier: Abdallah Hassan
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Keywords

DH, dentin hypersensitivity, chronic periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Probing pocket depth

  baseline and after 8 weeks

• Gingival recession (GR)

  baseline and after 8 weeks

Study Arms (2)

Strontium acetate toothpaste

ACTIVE COMPARATOR

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

Other: use of strontium acetate toothpaste

Arginine/calcium carbonate toothpaste

EXPERIMENTAL

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

Interventions

8% L-Arginine/calcium carbonate containing toothpaste OTHER

use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity

Arginine/calcium carbonate toothpaste

use of strontium acetate toothpaste OTHER

use of strontium acetate toothpaste to relieve hypersensitivity

Strontium acetate toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity; Chronic Periodontitis

Interventions

Arginine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Diseases; Mouth Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Prof.Dr. Manal Hosni

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR. Abdallah Hassan

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: January 1, 2018
• Primary Completion: March 3, 2018
• Study Completion: April 1, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

EG (1)