Dental Age Estimation MethodsNCT04817358
Genetic Influences on Dental Maturation: A Twin Study
An observational study of Dental Age Estimation Methods, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The genetics has been shown as one of the most important factor influencing the growth and development of the dentofacial complex. Dental development, one of the most reliable indicators of chronological age (CA), has been believed to be fundamentally influenced by genetics rather than environmental factors. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Age Estimation Methods
- How many people
- 171 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2021
- How long will I take part?
- 3 Years
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of MZ and DZ pairs between the ages of 5.0 and 12.9 who attended to the Department of Pedodontics at Suleyman Demirel University and underwent radiological examination for any dental reason during the dental treatment period from January 2018 to January 2021
Who may be able to join
- good quality of panoramic radiographs, presence of all permanent mandibular and maxillar teeth except the third molars
- healthy children with normal eruption of teeth,
- children with similiar etnic origin and socio-economic status
Who cannot join
- Children with any syndromes, congenital or developmental anomalies and systemic diseases,
- Children undergoing or with previous orthodontic treatment history,
- Children with tooth agenesis, dental trauma history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Faculty of Dentistry
Isparta
About this study
The genetics has been shown as one of the most important factor influencing the growth and development of the dentofacial complex. Dental development, one of the most reliable indicators of chronological age (CA), has been believed to be fundamentally influenced by genetics rather than environmental factors. As twins share genetic variation (100% for monozygotic and 50% for dizygotic twins) and were subjected to the similar environmental factors, the twin studies have been presented useful and effective method to researchers for investigating the influence of heredity on dental development and observing the similarities and differences among twin pairs.
Evaluation of dental development is among the most commonly used and reliable method for dental age determination using the morphological parameters of teeth on dental radiographs. Dental maturity, defined as a dental age (DA), is very important in forensic anthropology to identify cases and in dentistry for planning pedodontic and orthodontic treatment, and also determining a child's growth and developmental status.
There are many dental age estimation methods which are mostly based on the morphological evaluation of dental growth observed from dental radiographs in children In order to estimate dental age, Demirjian's, Willems' and Nolla's methods were used. All panoramic radiographs were scored by one observer to eliminate the inter-observer error.
- Conditions
- Dental Age Estimation Methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Demirjian method | According to the Demirjian method, the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls | |
| Willems method | Willems' method was determined using the Demirjian calcification stages but scores were evaluated according to Willems' specific tables | |
| Nolla method | In the Nolla method, the development of seven left mandibular and maxillar teeth were defined on 10 stages. If the tooth was between stages an appropriate fraction (0.2, 0.5 or 0.7) was added. The total score was determined according to the tables prepared for girls and boys as recommended by Nolla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demirjian method
the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls
Measured: up to 3 years
Secondary outcomes (1)
Willems method
Willems' method was determined using the Demirjian calcification stages but scores were evaluated according to Willems' specific tables
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Age Estimation MethodsStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 171 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Oz, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817358
- Sponsor's protocol ID
- 2018/232
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Influences on Dental Maturation: A Twin Study
- ClinicalTrials.gov ID
- NCT04817358
- Acronym / sponsor ID
- 2018/232
- Conditions
- Dental Age Estimation Methods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Mar 2021 (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 genetics has been shown as one of the most important factor influencing the growth and development of the dentofacial complex. Dental development, one of the most reliable indicators of chronological age (CA), has been believed to be fundamentally influenced by genetics rather than environmental factors. As twins share genetic variation (100% for monozygotic and 50% for dizygotic twins) and were subjected to the similar environmental factors, the twin studies have been presented useful and effective method to researchers for investigating the influence of heredity on dental development and observing the similarities and differences among twin pairs.
Evaluation of dental development is among the most commonly used and reliable method for dental age determination using the morphological parameters of teeth on dental radiographs. Dental maturity, defined as a dental age (DA), is very important in forensic anthropology to identify cases and in dentistry for planning pedodontic and orthodontic treatment, and also determining a child's growth and developmental status.
There are many dental age estimation methods which are mostly based on the morphological evaluation of dental growth observed from dental radiographs in children In order to estimate dental age, Demirjian's, Willems' and Nolla's methods were used. All panoramic radiographs were scored by one observer to eliminate the inter-observer error.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Demirjian method | – | –According to the Demirjian method, the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls |
| Willems method | – | –Willems' method was determined using the Demirjian calcification stages but scores were evaluated according to Willems' specific tables |
| Nolla method | – | –In the Nolla method, the development of seven left mandibular and maxillar teeth were defined on 10 stages. If the tooth was between stages an appropriate fraction (0.2, 0.5 or 0.7) was added. The total score was determined according to the tables prepared for girls and boys as recommended by Nolla |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of MZ and DZ pairs between the ages of 5.0 and 12.9 who attended to the Department of Pedodontics at Suleyman Demirel University and underwent radiological examination for any dental reason during the dental treatment period from January 2018 to January 2021
Key inclusion criteria (3 listed)
- good quality of panoramic radiographs, presence of all permanent mandibular and maxillar teeth except the third molars
- healthy children with normal eruption of teeth,
- children with similiar etnic origin and socio-economic status
Key exclusion criteria (3 listed)
- Children with any syndromes, congenital or developmental anomalies and systemic diseases,
- Children undergoing or with previous orthodontic treatment history,
- Children with tooth agenesis, dental trauma history
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
Demirjian method
Time frame: up to 3 years
the development of the seven left mandibular permanent teeth (except the third molar) were rated on the eight-stage scale from A to H. Each stage of mineralization was given a score, total dental maturity score was evaluated according to standard tables for boys and girls
1 secondary outcome
Willems method
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Age Estimation Methods, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demirjian method (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2021.