Efficacy of CPP-ACP on Bleaching Related Sensitivity

NCT04112706 | Completed FDA Drug

• 1 other identifier: IRB 200604706
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The purpose of this randomized controlled split-mouth clinical trial was to evaluate the effectiveness of MI paste in reducing sensitivity associated vital bleaching. Methods: 45 subjects were randomly divided into two groups, based upon which arch received MI Paste. Group 1 bleached Maxillary arch, Group 2 bleached mandibular arch. Two weeks later subjects stopped bleaching the first arch and started second arch. Sensitivity was measured by VAS daily log scale for two weeks. Shade was taken with colorimeter and Classic Vita shade guide at baseline, immediate post-bleaching, and two weeks post-bleaching. Longitudinal sensitivity over the 14 days period of bleaching was summarized. The Wilcoxon Signed Rank test was used to compare summary measures.

Conditions

Teeth Sensitivity; Tooth Discoloration

Outcome Measures

Primary Outcomes (2)

• Change in sensitivity measures related to bleaching: Subjective Sensitivity

  Thermal Sensitivity: Subjective Measure: Sensitivity was measured using thermal sensitivity scale (VAS) of 0-10, with 0 being "no pain" and 10 being "severe pain". Subjects were asked to pick a number. 2\. Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.

  28 DAYS

• Change in sensitivity measures related to bleaching: Objective Sensitivity

  Objective Measure: Thermal sensitivity was measured by using a 1-second air blast at 700F from dental unit air syringe as per American Dental Association (ADA) guidelines. A Scale of 0-3 was used to measure the pain response with 0 indicating "no pain" and 3 indicating the "severe pain" which lasted for more than 10 seconds.

  28 days

Secondary Outcomes (1)

• Shade change and interference of CPP-ACP with bleaching

  14 days

Interventions

CPP-ACP DRUG

CPP-ACP WAS APPLIED AFTER TOOTH BLEACHING

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients between the age of 18 and 50 years who were capable of providing informed consent. Subjects older than 50 were not included in the study because of more secondary dentine present less chances of developing sensitivity.
• Subject who had anterior tooth discoloration (equivalent to or darker than Vita shade A3).
• Subjects who were available for a potential recall period of one year.
• Subjects who had no severe systemic disorders. Subjects who needed antibiotics for prevention of spontaneous bacterial endocarditis (SBE) or artificial joints were included.

You may not qualify if:

• Subjects who had any known allergies to any materials used in this protocol.
• Patients with milk protein allergies since one of the materials used is derived from milk protein.
• Pregnant women were excluded from the study due to lack of available data for the safety of the bleaching gel for pregnant women.
• Subjects involved in other clinical trials utilizing a similar protocol.
• Subject who had used any dentist-supplied or over the counter vital tooth bleaching product in the previous six months.
• The subjects who have used any desensitizing agents including toothpaste in the past six months.
• Subjects who took COX-2 NSAIDs on daily basis or were under medical treatment at that time for major psychiatric illness that may have altered the perception of pain/discomfort and/or inhibit the subject from completing the study.
• Subjects who had any periodontal surgery or scaling performed in the past six months.

Sponsors & Collaborators

• University of New England: lead
• University of Iowa: collaborator

Study Sites (1)

University of New England

Portland, Maine, 04101, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity; Tooth Discoloration

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: Randomized controlled split-mouth

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 2, 2019
• Study Start: July 16, 2006
• Primary Completion: February 16, 2007
• Study Completion: March 16, 2007
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)