- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07935707
Changes in Bad Breath and Olfactory Function After Extraction of Carious Teeth
The Effect of Dental Caries on Halitosis Awareness and Olfactory Functions
This study aims to evaluate changes in halitosis and olfactory function in adults with advanced dental caries requiring tooth extraction.
A total of 80 adult patients aged 18-65 years with one or more teeth indicated for extraction due to advanced dental caries will be included. Tooth extractions will be performed under local anesthesia using an atraumatic technique as part of routine dental care. The extraction sockets will be allowed to heal by secondary intention.
Assessments will be performed before tooth extraction and 21 days after the last extraction. Halitosis will be evaluated by a single trained and blinded examiner using the organoleptic scoring method (OLS). Participants will also rate their perceived halitosis using a visual analog scale (VAS).
Olfactory function will be assessed using the Sniffin' Sticks test, which consists of three components: odor threshold, odor discrimination, and odor identification. The scores of these three tests will be combined to calculate the total TDI score.
The preoperative and postoperative results will be compared to investigate changes in halitosis and olfactory function following the removal of carious teeth.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Batman, Tyrkia (Türkiye)
- Batman University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
The study population consists of 80 adults aged 18-65 years with one or more teeth indicated for extraction due to advanced dental caries. Participants are systemically healthy, non-smokers, and have healthy periodontal tissues or have completed periodontal treatment before enrollment. Both male and female participants are included. Tooth extractions are performed under local anesthesia using an atraumatic technique as part of routine clinical care. Halitosis and olfactory function are assessed before tooth extraction and 21 days after the last tooth extraction. Participants who do not meet the eligibility criteria are excluded from the study.
Beskrivelse
Inclusion Criteria:
Adults aged 18-65 years. Patients with one or more teeth indicated for extraction due to advanced dental caries.
Systemically healthy individuals. Non-smokers. Individuals with healthy periodontal tissues or those who have completed periodontal treatment before enrollment.
Exclusion Criteria:
History of loss of smell or changes in olfactory function within the two weeks preceding the olfactory assessments and tooth extraction.
Use of antibiotics or anti-inflammatory medications for more than 7 consecutive days within the preceding 6 weeks.
Presence of an upper respiratory tract infection at the time of assessment. History of COVID-19 infection. Pregnancy. Lactation. Traumatic tooth extraction or extraction procedures requiring flap elevation. Development of alveolar osteitis (dry socket) during the postoperative follow-up period.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
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Adults Undergoing Extraction of Carious Teeth
This cohort consists of adults aged 18-65 years who underwent extraction of one or more teeth due to advanced dental caries as part of routine clinical care. Tooth extractions were performed under local anesthesia using an atraumatic technique, and the extraction sockets were allowed to heal by secondary intention. Participants underwent assessments of halitosis and olfactory function before tooth extraction and 21 days after the last extraction. Halitosis was evaluated using an organoleptic scoring method and a patient-reported visual analog scale (VAS). Olfactory function was assessed using the Sniffin' Sticks test, including threshold, discrimination, and identification components (TDI score). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Organoleptic Score (OLS) from Baseline to Follow-up
Tidsramme: At baseline (before tooth extraction) and 21 days after the last tooth extraction.
|
Halitosis will be assessed by a single trained and blinded examiner using the organoleptic scoring method (OLS). Participants will be instructed to keep their mouths closed, breathe through their noses, and then exhale through their mouths. The examiner will assess the odor of the exhaled breath using a 6-point scale ranging from 0 to 5, where 0 indicates no detectable odor and 5 indicates extremely strong odor. Changes in OLS scores between baseline (before tooth extraction) and follow-up will be evaluated. |
At baseline (before tooth extraction) and 21 days after the last tooth extraction.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Patient-Perceived Halitosis Severity (VAS) from Baseline to Follow-up
Tidsramme: At baseline (before tooth extraction) and 21 days after the last tooth extraction.
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Participants will assess their perceived halitosis severity using a 10-point visual analog scale (VAS), ranging from 0 (no perceived bad breath) to 10 (extremely severe bad breath). Changes in VAS scores between baseline (before tooth extraction) and follow-up will be evaluated. |
At baseline (before tooth extraction) and 21 days after the last tooth extraction.
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Change in Olfactory Function (Sniffin' Sticks TDI Score) from Baseline to Follow-up
Tidsramme: At baseline (before tooth extraction) and 21 days after the last tooth extraction.
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Olfactory function will be assessed using the Sniffin' Sticks test, consisting of three components: odor threshold (T), odor discrimination (D), and odor identification (I). The threshold test evaluates the lowest odor concentration that participants can detect. The discrimination test assesses the ability to distinguish between different odors, while the identification test evaluates the ability to identify familiar odors from multiple-choice options. The scores of the three components will be summed to obtain the total TDI score. Changes in total TDI scores between baseline and follow-up will be evaluated. |
At baseline (before tooth extraction) and 21 days after the last tooth extraction.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026/02-03
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