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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Melis Ballıkara, DDS
- 電話番号：+90 533 889 90 02
- メール：melis.ballikara@kstu.edu.tr
研究場所
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Northern Cyprus
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Mórfou、Northern Cyprus、キプロス、99750
- Cyprus Health and Social Sciences University, Faculty of Dentistry
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コンタクト：
- Melis Ballıkara, DDS
- 電話番号：+90 533 889 90 02
- メール：melisballikara@gmail.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Full-Mouth Plaque Score (FMPS)
時間枠：Baseline, 1 month, and 3 months after treatment
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Bleeding on Probing (BOP)
時間枠：Baseline, 1 month, and 3 months after treatment
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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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Probing Pocket Depth (PPD)
時間枠：Baseline, 1 month, and 3 months after treatment
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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
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|
Change in Clinical Attachment Level (CAL)
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- KSTU-PERIO-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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