Enamel Abrasion and Stain Removal Efficacy of Two Whitening Toothpastes: An In-vitro and In-vivo Trial
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
The aim of the study is to clinically evaluate the efficacy of external stain removal of an activated charcoal based tooth paste versus calcium carbonate /perlite tooth paste. Additionally, to investigate enamel surface abrasion for both toothpastes in vitro.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedDecember 28, 2022
December 1, 2022
5 months
November 24, 2022
December 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stain scores as per Macpherson modification of the Lobene stain index
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (\< 1/3) 2. thick line or band (\>1/3, \<2/3) 3. covering total area (\> 2/3)
Baseline
Stain scores as per Macpherson modification of the Lobene stain index
Stain scores will be recorded as per the Macpherson modified Lobene Stain Index area x intensity (AXI). Each tooth will be divided into four areas for assessment: gingival, mesial, distal and body. The stain index will measure area and intensity of extrinsic tooth stain on the facial surfaces of the anterior teeth. The criteria and codes for intensity were: 0: no stain present, natural tooth colouration 1. faint stain 2. clearly visible stain, orange to brown (moderate stain) 3. dark stain, deep brown to black (heavy stain) The area (extent) of the stain was recorded only if an intensity score was of 2 or 3 The area criteria and codes for approximal and gingival sites were: 1. thin line, can be continuous (\< 1/3) 2. thick line or band (\>1/3, \<2/3) 3. covering total area (\> 2/3)
after four weeks
Other Outcomes (1)
enamel abrasion using atomic force microscopy before and after brushing (Anton Paar - Tosca™ 200 - atomic force microscope, USA.)
3 minutes equivalent to 2 times a day for one month
Study Arms (2)
Charcoal -based whitening toothpaste
EXPERIMENTALsignal charcoal white\& Detox toothpaste Unilever Mashreq - Egypt
Calcium carbonate /perlite containing whitening toothpaste
ACTIVE COMPARATORsignal whitening moonlight toothpaste Unilever Mashreq - Egypt
Interventions
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6 hours) for at least 1 minute using charcoal containing toothpaste. Soft bristles toothbrushes will provided to all patients (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. Intervention drug : whitening toothpaste charcoal based whitening toothpaste compared to calcium carbonate and perlite whitening toothpaste FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush (Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination
The labial surface of anterior teeth will be brushed by the circular brushing technique twice daily (morning and after 6hours) for at least 1 minute using calcium carbonate /perlite containing toothpaste. Soft bristles toothbrushes will provided to all patients (Oral-B). After 1 month, re-evaluation of the stains will be performed and the data will be recorded. The main operator will perform the tooth brushing procedures for all the patients himself twice daily. FOR IN VITRO: Human premolars will be obtained from volunteers due to orthodontic reasons. Teeth will be divided into two equal groups (n:18) according to the toothpaste used. Teeth will be brushed with an electric tooth brush(Oral-B PRO 500) that will be held in a holder to standardize the position to the tooth surface for 3 minutes equivalent to 2 times a day for one month. Teeth will be prepared for AFM examination Device used is atomic force microscopy to determine enamel abrasion after brushing
Eligibility Criteria
You may qualify if:
- Adult male and female patients ≥18 years.
- Good oral and general health and oral hygiene have at least eight natural anterior teeth (incisors and canines) assessable for extrinsic stain and be available for all study appointments.
You may not qualify if:
- Uncooperative behavior.
- Patients allergic to tooth paste material.
- Patient with history of medical disease, drug therapies or any other serious relevant problem.
- Pregnant or breastfeeding women.
- Patients with fixed orthodontic appliances
- Patients who had professional tooth whitening, within the last six months.
- Patients who had significant amounts of calculus on facial surfaces of the incisors/canines.
- Patients who had undergone professional periodontal treatment within the previous six months or used mouth rinses for the treatment/ control of a periodontal condition.
- Patients who had advanced periodontal disease on anterior teeth.
- Xerostomic patients.
- Patients who used medications which could affect saliva flow or cause staining.
- Patients who had undergone dental prophylaxis within 8 weeks of screening.
- Patients who used minocycline or doxycycline within 30 days of screening or between screening and baseline.
- ▪ Vital anterior maxillary and mandibular teeth free of caries or restorations, no cervical lesions and no periodontal disease.
- Intrinsically Discolored teeth caused by tetracycline, fluorosis, hypocalcification hyperplasia, endodontic treatment (or requiring endodontic treatment).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iman I ElSayad
Cairo University
- STUDY DIRECTOR
Mohamed R El-Bialy, Post Phd
Cairo University
Central Study Contacts
Mohamed R El-Bialy, Post Phd
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master student, conservative department, faculty of dentistry
Study Record Dates
First Submitted
November 24, 2022
First Posted
December 14, 2022
Study Start
January 1, 2023
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share