Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity
Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial
연구 개요
상태
정황
상세 설명
This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.
A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:
Group 1 received Nd:YAG laser application.
Group 2 received Diode laser application.
Group 3 received a topical application of a herbal propolis-based dentin barrier agent.
Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.
Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Samsun
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Samsun, Samsun, 터키 (Türkiye), 55270
- Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged between 18 and 65 years.
- Presence of at least two hypersensitive teeth.
- Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
- Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
- Presence of vital teeth in the target area.
- Patient is willing and able to provide written informed consent prior to study initiation.
Exclusion Criteria:
- Pregnancy or lactation.
- Presence of active periodontal disease in the target area.
- Teeth with dental caries, deep restorations, or cracked tooth syndrome.
- Endodontically treated teeth.
- History of allergy or hypersensitivity related to the materials, products, or chemical agents used in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1: Nd:YAG Laser
Participants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization.
The procedure was completed during the treatment session according to the clinical protocol.
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Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
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실험적: Group 2: Diode Laser
Participants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment.
The application was performed in accordance with the specified parameters.
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Diode laser application performed for the treatment of dentine hypersensitivity.
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실험적: Group 3: Dentin Barrier Agent
Participants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces.
The agent was applied to seal the dentinal tubules and reduce sensitivity.
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Topical application of a herbal propolis-based dentin barrier agent.
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가짜 비교기: Group 4: Sham Application
Participants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent.
This group served as the control to account for the placebo effect.
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Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Visual Analog Scale (VAS) Score after Air Stimulus
기간: Baseline and 6 months
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Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain).
The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
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Baseline and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Schiff Cold Air Sensitivity Scale Score
기간: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Dentine sensitivity assessed using the Schiff Cold Air Sensitivity Scale, where scores range from 0 (patient does not respond to air stimulus) to 3 (patient responds to air stimulus, experiences pain, and requests discontinuation of stimulus).
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Tactile Sensitivity Score
기간: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Tactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- 2025000326-2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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