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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Melis Ballıkara, DDS
- 전화번호: +90 533 889 90 02
- 이메일: melis.ballikara@kstu.edu.tr
연구 장소
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Northern Cyprus
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Mórfou, Northern Cyprus, 키프로스, 99750
- Cyprus Health and Social Sciences University, Faculty of Dentistry
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연락하다:
- Melis Ballıkara, DDS
- 전화번호: +90 533 889 90 02
- 이메일: melisballikara@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Full-Mouth Plaque Score (FMPS)
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Bleeding on Probing (BOP)
기간: 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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Probing Pocket Depth (PPD)
기간: 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)
기간: Baseline, 1 month, and 3 months after treatment
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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
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- KSTU-PERIO-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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