- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Batman, Turecko (Türkiye)
- Batman University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
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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). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Organoleptic Score (OLS) from Baseline to Follow-up
Časové okno: At baseline (before tooth extraction) and 21 days after the last tooth extraction.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Patient-Perceived Halitosis Severity (VAS) from Baseline to Follow-up
Časové okno: 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
Časové okno: 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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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