Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling (HA35)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Topical 10% 35 kDa Hyaluronan (HA35) Gel for Post-Dental Gingival Pain and Swelling
연구 개요
상태
정황
상세 설명
This prospective, single-center, single-arm, open-label pilot clinical study investigates the analgesic and anti-inflammatory efficacy of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls for managing gingival pain and swelling following dental procedures (including restoration, transplantation, extraction, and scaling).
Eligible subjects will place HA35 gel-soaked sterile cotton balls on the affected gingival area, gently chew and retain the cotton balls in place for 30 minutes to allow sustained local infiltration. Pain intensity will be assessed using a 0-10 Numeric Rating Scale (NRS), and gingival swelling using a 0-10 Visual Analog Scale (VAS) at baseline, 1 minute, 30 minutes, and 60 minutes after application.
Oral irritation, allergic reactions, and adverse events will be monitored for safety assessment.
This is a non-invasive, non-pharmacological oral topical intervention with minimal risk to participants. All procedures will be conducted in accordance with the Declaration of Helsinki, and written informed consent will be obtained from all subjects prior to enrollment.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-65 years, male or female
- Experienced gingival pain and swelling within 12 hours after dental procedures
- Baseline gingival pain NRS score ≥2
- Able to independently complete pain and swelling assessments
- Signed written informed consent
Exclusion Criteria:
- Severe periodontitis, uncontrolled diabetes, or immune dysfunction
- Long-term use of analgesics or anti-inflammatory drugs
- Known hypersensitivity to hyaluronan or gel components
- Oral infection, ulceration, or severe mucosal injury at the application site
- Pregnant or lactating women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HA35 Gel Topical Application Group
Participants receive 10% high-concentration 35 kDa HA35 gel delivered via gel-soaked cotton balls, which are gently chewed and held in the affected gingival area for 30 minutes to allow sustained local infiltration.
Efficacy on gingival pain, swelling, and safety will be evaluated.
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Topical oral gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Delivered via gel-soaked cotton balls that are gently chewed and retained in the mouth for sustained infiltration into the affected gingival area to relieve post-dental pain and reduce swelling.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Gingival Pain NRS Score (0-10)
기간: Baseline to 1, 30, and 60 minutes after application
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Change in post-dental gingival pain intensity measured by 0-10 NRS, 0 = no pain, 10 = worst imaginable pain.
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Baseline to 1, 30, and 60 minutes after application
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Gingival Swelling Severity (0-10 VAS Score)
기간: Baseline to 1, 30, and 60 minutes after application
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Change in gingival swelling severity at the treatment site, assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no swelling and 10 = maximum swelling.
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Baseline to 1, 30, and 60 minutes after application
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Onset Time of Gingival Pain Relief
기간: Within 60 minutes after application
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Time from application to the first reported reduction in gingival pain intensity of ≥2 points on a 0-10 Numeric Rating Scale (NRS).
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Within 60 minutes after application
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Incidence and Severity of Oral Adverse Events
기간: Throughout the 60-minute observation period
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Number and severity of treatment-related oral adverse events (e.g., irritation, numbness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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Throughout the 60-minute observation period
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공동 작업자 및 조사자
스폰서
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
- HA35202606
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