EFFECTS OF PHASE I PERIODONTAL THERAPY IN CIGARETTE SMOKERS, HEATED TOBACCO PRODUCT USERS, DUAL USERS, AND NON-SMOKERS
EVALUATION OF THE EFFECTS OF CONVENTIONAL CIGARETTE SMOKING, HEATED TOBACCO PRODUCT USE, AND DUAL USE ON PHASE I PERIODONTAL THERAPY OUTCOMES
This prospective, comparative clinical study aims to evaluate the periodontal status and response to Phase I periodontal therapy among conventional cigarette smokers, heated tobacco product users, dual users of conventional cigarettes and heated tobacco products, and non-smokers.
The study includes systemically healthy individuals aged 18-35 years diagnosed with generalized gingivitis. Participants are categorized into four groups according to their existing tobacco use habits.
Periodontal assessments include full-mouth plaque score (FMPS), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL). All participants receive conventional Phase I periodontal therapy and standardized oral hygiene instructions as part of routine periodontal care.
Clinical periodontal parameters are evaluated at baseline and at one and three months following treatment. The study aims to compare periodontal outcomes and changes over time among the four tobacco use groups.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Melis Ballıkara, DDS
- Telefonní číslo: +90 533 889 90 02
- E-mail: melis.ballikara@kstu.edu.tr
Studijní místa
-
-
Northern Cyprus
-
Mórfou, Northern Cyprus, Kypr, 99750
- Cyprus Health and Social Sciences University, Faculty of Dentistry
-
Kontakt:
- Melis Ballıkara, DDS
- Telefonní číslo: +90 533 889 90 02
- E-mail: melisballikara@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Individuals aged 18-35 years.
Systemically healthy individuals.
Individuals diagnosed with generalized gingivitis.
Individuals belonging to one of the following four groups:
Conventional cigarette smokers.
Heated tobacco product (HTP) users.
Dual users of conventional cigarettes and heated tobacco products.
Non-users of tobacco products.
Individuals who voluntarily agree to participate in the study and provide written informed consent.
Exclusion Criteria:
Individuals with a current or previous diagnosis of periodontitis.
Individuals currently undergoing orthodontic treatment.
Individuals using medications that may affect periodontal health.
Individuals who have used antibiotics within the previous 3 months.
Pregnant or breastfeeding individuals.
Individuals who have received periodontal treatment within the previous 6 months.
Individuals with current alcohol dependence.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Phase I Periodontal Therapy
Participants aged 18-35 years diagnosed with generalized gingivitis receive Phase I periodontal therapy and standardized oral hygiene instructions. Participants are categorized into four subgroups according to their pre-existing tobacco use status: conventional cigarette smokers, heated tobacco product users, dual users, and non-smokers. Periodontal parameters, including full-mouth plaque score (FMPS), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL), are assessed at baseline and at 1 and 3 months following treatment. |
All participants diagnosed with generalized gingivitis will receive conventional non-surgical Phase I periodontal therapy, including professional scaling and standardized oral hygiene instructions. Participants will be assessed at baseline and at one and three months following treatment. Periodontal treatment outcomes will be evaluated using full-mouth plaque score (FMPS), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL). The same treatment approach will be applied across all four tobacco use groups. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Full-Mouth Plaque Score (FMPS)
Časové okno: Baseline, 1 month, and 3 months after treatment
|
Full-mouth plaque score (FMPS) will be assessed using the O'Leary plaque control record. The presence or absence of dental plaque will be recorded at four surfaces per tooth without a disclosing agent. FMPS will be expressed as the percentage of plaque-positive surfaces. Changes in FMPS following Phase I periodontal therapy will be compared among the four tobacco use groups. |
Baseline, 1 month, and 3 months after treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Bleeding on Probing (BOP)
Časové okno: Baseline, 1 month, and 3 months after treatment
|
Bleeding on probing (BOP) will be assessed using the Ainamo and Bay Gingival Bleeding Index. Bleeding will be recorded dichotomously as present (1) or absent (0) following gentle periodontal probing. BOP will be expressed as the percentage of bleeding-positive sites. Changes in BOP following Phase I periodontal therapy will be compared among conventional cigarette smokers, heated tobacco product users, dual users, and non-smokers. |
Baseline, 1 month, and 3 months after treatment
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Probing Pocket Depth (PPD)
Časové okno: Baseline, 1 month, and 3 months after treatment
|
Probing pocket depth (PPD) will be measured in millimeters using a UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). PPD is defined as the distance from the gingival margin to the base of the gingival sulcus or periodontal pocket. Changes in PPD following Phase I periodontal therapy will be evaluated at baseline, one month, and three months and compared among the four tobacco use groups. |
Baseline, 1 month, and 3 months after treatment
|
|
Change in Clinical Attachment Level (CAL)
Časové okno: Baseline, 1 month, and 3 months after treatment
|
Clinical attachment level (CAL) will be measured in millimeters using a UNC-15 periodontal probe at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). CAL is defined as the distance from the cementoenamel junction (CEJ) to the base of the gingival sulcus or periodontal pocket. Changes in CAL following Phase I periodontal therapy will be assessed at baseline, one month, and three months and compared among the four tobacco use groups. |
Baseline, 1 month, and 3 months after treatment
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Hasan NWM, Baharin B, Mohd N, Rahman MA, Hassan N. Comparative effects of e-cigarette smoking on periodontal status, salivary pH, and cotinine levels. BMC Oral Health. 2024 Jul 29;24(1):861. doi: 10.1186/s12903-024-04650-7.
- Camoni N, Conti G, Esteves-Oliveira M, Carvalho TS, Roccuzzo A, Cagetti MG, Campus G. Electronic Cigarettes, Heated Tobacco Products, and Oral Health: A Systematic Review and Meta-Analysis. Applied Sciences. 2023;13(17):9654. doi:10.3390/app13179654.
- Alshibani N, Alssum L, Basudan A, Shaheen M, Alqutub MN, Dahash FA, Alkattan R. Non-surgical periodontal therapy with adjunct photodynamic therapy for the management of periodontal inflammation in adults using nicotine-free electronic-cigarette: A randomized control trial. Photodiagnosis Photodyn Ther. 2022 Jun;38:102820. doi: 10.1016/j.pdpdt.2022.102820. Epub 2022 Mar 21.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
Další identifikační čísla studie
- KSTU-PERIO-2026-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The individual participant data (IPD) sharing plan has not yet been finalized. The possibility of sharing de-identified data will be evaluated in accordance with ethical approval, participant consent, and applicable data protection requirements.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .