Discoloration, ToothNCT06515561
Prevalence of Teeth Discoloration , Associated Risk Factors and the Most Common Shade Among Group of Egyptian Population
An observational study of Discoloration, Tooth, run by Cairo University.
Trial summary
"The aim of this study is to assess the prevalence of tooth discoloration and explore its associated risk factors, including local cultural practices or environmental conditions, among a group of adults aged 20 to 45 years in an Egyptian population sample. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Discoloration, Tooth
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Adult
Study population: Egyptian adults of both sexes aged 20-45 years from outpatient clinic, Faculty of Dentistry, Cairo University.
Who may be able to join
- Age 20-45 years.
- Males or females.
- Egyptians.
- Presence of at least 20 teeth in function.
- Patient compliance.
Who cannot join
- Psychologically unstable or mentally retarded participants
- Participants with severe periodontal diseases.
- Participants in need for emergency intervention
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Teeth Discoloration and Associated Risk Factors and Determination of the Most Common Shade Among Group of Egyptian Population: Educational Hospital Based Cross Sectional Study
"The aim of this study is to assess the prevalence of tooth discoloration and explore its associated risk factors, including local cultural practices or environmental conditions, among a group of adults aged 20 to 45 years in an Egyptian population sample. Moreover, we aim to identify the most common dental shades in the same sample."
Read the detailed description
Discoloration of teeth is a frequent dental finding and it is often esthetically displeasing and psychologically traumatizing to the patient (Manuel et al., 2010). Changes in the three distinct layers of the tooth; enamel, dentin and cementum are known to cause modification in the appearance of the teeth leading to a change in its light transmission and reflection properties (Watts et al., 2001). Generally, tooth discoloration is said to have occurred when there is a deviation in tooth color. Suresh and Gopi in 2010 noted that the normal color of primary teeth is bluish white, whereas the color of permanent teeth is grayish white or yellowish white. The teeth of adults usually appear more yellow or grayish yellow than those of younger persons because as one ages, the enamel becomes thinner from physiological wear, while the dentin becomes thicker from the deposition of secondary dentin. There are two types of tooth discoloration, extrinsic and intrinsic, while the extrinsic type is apparent on the outer surface of the teeth, the intrinsic type stains are coming from inside of the teeth. The main cause of intrinsic tooth discoloration is the decomposition of pulp tissue, which is the first indication of pulp death (Suresh \& Gopi., 2010). Other causes of intrinsic tooth discoloration are enamel opacities, dental caries, tetracycline, minocycline and doxycycline staining, and enamel hypoplasia (Koleoso et al., 2004). These medications can leave a characteristic bright-yellow band that fluoresces under ultraviolet light (tetracycline) or a green-gray or blue-gray intrinsic staining (minocycline). Also, Fluoride can cause enamel discoloration through hypomineralization when too much of it is ingested during the early maturation stage of enamel formation. In addition, dental materials used for dental restorations like amalgam restorations, can generate corrosion products such as silver sulfide which can leave a gray-black color on the teeth.
On the other hand, extrinsic dental discoloration might be due to tea, coffee, tobacco smoking/chewing, betel nut chewing, drugs (e.g., chlorhexidine mouth rinse), iron salts, heavy metals (e.g., silver nitrate and lead), essential oils, amoxicillin-clavulinic acid, ciprofloxacin, linezolide, and glibenclamide (Kumar et al., 2012). Enamel defects, salivary dysfunction, and poor oral hygiene could be predisposing factors to extrinsic discoloration. Small pits and defects on the outer surface of the enamel can lead to an accumulation of food particles and stains from beverages, tobacco, and other topical agents on its surface causing the discoloration. Salivary dysfunction such as, decreased salivation can lead to difficulties in removing food debris from the tooth surface and can thus contribute to the staining of teeth. Conditions that are associated with a reduction in the salivation are salivary gland obstruction and infection, Sjögren syndrome, head and neck radiation therapy for cancer, chemotherapy, and multiple medications (e.g., anticholinergics, antihypertensive, antipsychotics and antihistamines). All of these can cause teeth discoloration (Patel et al., 2013).
- Conditions
- Discoloration, Tooth
- Medical subject headings
- Tooth Discoloration
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence and severity of discoloration
assessment of the prevalence and severity of dental discoloration among adults in the study area.
Measured: 3 months
Secondary outcomes (2)
risk factors and their association with discoloration
Identification of risk factors and their association with discoloration in the study population and knowing the most common teeth shade among the same group of population.
Measured: 3 months
Most common teeth shade
determination of most common teeth shade usingVita classical shade guide
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Saber Abd Al Aziz, Cairo University
- Investigators
- Asmaa Yassen, ph degree, Study director, Professor at Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515561
- Sponsor's protocol ID
- PREVELANCE OF DISCOLORATION
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koleoso DC, Shaba OP, Isiekwe MC. Prevalence of intrinsic tooth discolouration among 11-16 year-old Nigerians. Odontostomatol Trop. 2004 Jun;27(106):35-9.
PubMed 15536720
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Teeth Discoloration and Associated Risk Factors and Determination of the Most Common Shade Among Group of Egyptian Population: Educational Hospital Based Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06515561
- Acronym / sponsor ID
- PREVELANCE OF DISCOLORATION
- Conditions
- Discoloration, Tooth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"The aim of this study is to assess the prevalence of tooth discoloration and explore its associated risk factors, including local cultural practices or environmental conditions, among a group of adults aged 20 to 45 years in an Egyptian population sample. Moreover, we aim to identify the most common dental shades in the same sample."
Detailed description
Discoloration of teeth is a frequent dental finding and it is often esthetically displeasing and psychologically traumatizing to the patient (Manuel et al., 2010). Changes in the three distinct layers of the tooth; enamel, dentin and cementum are known to cause modification in the appearance of the teeth leading to a change in its light transmission and reflection properties (Watts et al., 2001). Generally, tooth discoloration is said to have occurred when there is a deviation in tooth color. Suresh and Gopi in 2010 noted that the normal color of primary teeth is bluish white, whereas the color of permanent teeth is grayish white or yellowish white. The teeth of adults usually appear more yellow or grayish yellow than those of younger persons because as one ages, the enamel becomes thinner from physiological wear, while the dentin becomes thicker from the deposition of secondary dentin. There are two types of tooth discoloration, extrinsic and intrinsic, while the extrinsic type is apparent on the outer surface of the teeth, the intrinsic type stains are coming from inside of the teeth. The main cause of intrinsic tooth discoloration is the decomposition of pulp tissue, which is the first indication of pulp death (Suresh \& Gopi., 2010). Other causes of intrinsic tooth discoloration are enamel opacities, dental caries, tetracycline, minocycline and doxycycline staining, and enamel hypoplasia (Koleoso et al., 2004). These medications can leave a characteristic bright-yellow band that fluoresces under ultraviolet light (tetracycline) or a green-gray or blue-gray intrinsic staining (minocycline). Also, Fluoride can cause enamel discoloration through hypomineralization when too much of it is ingested during the early maturation stage of enamel formation. In addition, dental materials used for dental restorations like amalgam restorations, can generate corrosion products such as silver sulfide which can leave a gray-black color on the teeth.
On the other hand, extrinsic dental discoloration might be due to tea, coffee, tobacco smoking/chewing, betel nut chewing, drugs (e.g., chlorhexidine mouth rinse), iron salts, heavy metals (e.g., silver nitrate and lead), essential oils, amoxicillin-clavulinic acid, ciprofloxacin, linezolide, and glibenclamide (Kumar et al., 2012). Enamel defects, salivary dysfunction, and poor oral hygiene could be predisposing factors to extrinsic discoloration. Small pits and defects on the outer surface of the enamel can lead to an accumulation of food particles and stains from beverages, tobacco, and other topical agents on its surface causing the discoloration. Salivary dysfunction such as, decreased salivation can lead to difficulties in removing food debris from the tooth surface and can thus contribute to the staining of teeth. Conditions that are associated with a reduction in the salivation are salivary gland obstruction and infection, Sjögren syndrome, head and neck radiation therapy for cancer, chemotherapy, and multiple medications (e.g., anticholinergics, antihypertensive, antipsychotics and antihistamines). All of these can cause teeth discoloration (Patel et al., 2013).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Egyptian adults of both sexes aged 20-45 years from outpatient clinic, Faculty of Dentistry, Cairo University.
Key inclusion criteria (5 listed)
- Age 20-45 years.
- Males or females.
- Egyptians.
- Presence of at least 20 teeth in function.
- Patient compliance.
Key exclusion criteria (3 listed)
- Psychologically unstable or mentally retarded participants
- Participants with severe periodontal diseases.
- Participants in need for emergency intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence and severity of discoloration
Time frame: 3 months
assessment of the prevalence and severity of dental discoloration among adults in the study area.
2 secondary outcomes
risk factors and their association with discoloration
Time frame: 3 months
Most common teeth shade
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 15536720Koleoso DC, Shaba OP, Isiekwe MC. Prevalence of intrinsic tooth discolouration among 11-16 year-old Nigerians. Odontostomatol Trop. 2004 Jun;27(106):35-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa Yassen, ph degree study director
Professor at Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Questions about this trial
What is this clinical trial studying?
An observational study of Discoloration, Tooth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara saber, master (00201152766226, sara.saber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence and severity of discoloration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.