Decay, DentalNCT06017570
Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars
A study testing Radiologic examination on orthopantomogram and Clinical examination after surgery in people with Decay, Dental and Impacted Third Molar Tooth, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and external root resorption. The incidence of caries is high, especially in partially impacted third molars in mesioangular and horizontal positions. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Decay, Dental, Impacted Third Molar Tooth
- What is being tested?
- Radiologic examination on orthopantomogram and Clinical examination after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2023to 18 Jan 2024
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between 20 and 40 years old
- having a surgery appointment for removal of the partially impacted third molar which is mesioangular or horizontal position
- having an orthopantomogram on the database
- and having a second molar adjacent to the impacted third molar
Who cannot join
- crowned or restored the second molar
- any surgery related to the contact area
- any pathology related to the second or third molar
- a radiological artifact on the contact area
- insufficient radiological quality for the evaluation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Dentistry
Konya, Selçuklu
About this study
Official title: Risk Factors for Distal Caries of Second Molars Adjacent to Mesioangular or Horizontal Partially Erupted Mandibular Third Molars, A Cross-Sectional Study
Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and external root resorption. The incidence of caries is high, especially in partially impacted third molars in mesioangular and horizontal positions. In this study, investigators aimed to examine the caries correlation in the distal second molar with the age, gender, side and DMFT scores of the participants.
- Conditions
- Decay, Dental, Impacted Third Molar Tooth
- Being tested
- Radiologic examination on orthopantomogram, Clinical examination after surgery
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiologic examination on orthopantomogramDiagnostic test
Caries examination on the distal side of the adjacent second molar in the orthopantomogram of patients with an appointment for the extraction of mesioangular or horizontal partially impacted third molars
Clinical examination after surgeryDiagnostic test
İnspectional caries examination on the distal side of the adjacent second molar after surgery of patients with mesioangular or horizontal partially impacted third molars
| Study group | Role | What they receive |
|---|---|---|
| Low-risk Group | Experimental | Participants with DMFT score: 0 or 1. Receives: Diagnostic Test: Radiologic examination on orthopantomogram; Diagnostic Test: Clinical examination after surgery |
| Modarate-risk Group | Experimental | Participants with DMFT score: 2, 3, 4 or 5. Receives: Diagnostic Test: Radiologic examination on orthopantomogram; Diagnostic Test: Clinical examination after surgery |
| High-risk Group | Experimental | Participants with DMFT score above 5. Receives: Diagnostic Test: Radiologic examination on orthopantomogram; Diagnostic Test: Clinical examination after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologic examination
Radiologic examination on the distal side of the second molar for tooth decay
Measured: 10 minute before the start of surgery
Intra-oral examination
Obtaining DMFT score
Measured: 10 minute before the start of surgery
Clinical examination
Clinical examination (intra-oral) on the distal side of the second molar for tooth decay
Measured: 1 minutes after the removal of third molar
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start5 Oct 2023
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decay, DentalStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Gurses, Selcuk University
- Investigators
- Gökhan Gürses, Study chair, Selcuk University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017570
- Sponsor's protocol ID
- SelcukU003
- Status last verified
- Jan 2024
- First submitted
- 24 Aug 2023
- Last updated
- 19 Jan 2024
- 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Distal Caries of Second Molars Adjacent to Mesioangular or Horizontal Partially Erupted Mandibular Third Molars, A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06017570
- Acronym / sponsor ID
- SelcukU003
- Conditions
- Decay, Dental, Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 30 Aug 2023 (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.
Distal surfaces of second molars adjacent to wisdom teeth are always at risk for caries and external root resorption. The incidence of caries is high, especially in partially impacted third molars in mesioangular and horizontal positions. In this study, investigators aimed to examine the caries correlation in the distal second molar with the age, gender, side and DMFT scores of the participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-risk Group | Experimental | Diagnostic Test: Radiologic examination on orthopantomogram, Diagnostic Test: Clinical examination after surgeryParticipants with DMFT score: 0 or 1. |
| Modarate-risk Group | Experimental | Diagnostic Test: Radiologic examination on orthopantomogram, Diagnostic Test: Clinical examination after surgeryParticipants with DMFT score: 2, 3, 4 or 5. |
| High-risk Group | Experimental | Diagnostic Test: Radiologic examination on orthopantomogram, Diagnostic Test: Clinical examination after surgeryParticipants with DMFT score above 5. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being between 20 and 40 years old
- having a surgery appointment for removal of the partially impacted third molar which is mesioangular or horizontal position
- having an orthopantomogram on the database
- and having a second molar adjacent to the impacted third molar
Key exclusion criteria (5 listed)
- crowned or restored the second molar
- any surgery related to the contact area
- any pathology related to the second or third molar
- a radiological artifact on the contact area
- insufficient radiological quality for the evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiologic examination on orthopantomogramCaries examination on the distal side of the adjacent second molar in the orthopantomogram of patients with an appointment for the extraction of mesioangular or horizontal partially impacted third molars | Diagnostic test | High-risk Group, Low-risk Group, Modarate-risk Group |
| Clinical examination after surgeryİnspectional caries examination on the distal side of the adjacent second molar after surgery of patients with mesioangular or horizontal partially impacted third molars | Diagnostic test | High-risk Group, Low-risk Group, Modarate-risk Group |
Primary outcome
Radiologic examination
Time frame: 10 minute before the start of surgery
Radiologic examination on the distal side of the second molar for tooth decay
Intra-oral examination
Time frame: 10 minute before the start of surgery
Obtaining DMFT score
Clinical examination
Time frame: 1 minutes after the removal of third molar
Clinical examination (intra-oral) on the distal side of the second molar for tooth decay
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 19 Jan 2024.
- 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.
Gökhan Gürses study chair
Selcuk University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiologic examination on orthopantomogram and Clinical examination after surgery in people with Decay, Dental and Impacted Third Molar Tooth, run by Selcuk 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 4 inclusion and 5 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 19 Jan 2024. 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?
Radiologic examination (time frame: 10 minute before the start of surgery). The study lists 3 primary outcomes in all. 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 19 Jan 2024.