Gingival Hyperpigmentation Treatment
Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
연구 개요
상세 설명
Over the last decade, an increasing interest has been observed in esthetic treatments. In fact, The smile is an important aesthetic component of the face and significantly impacts the perception of beauty and psychological well-being. Gingival hyperpigmentation has been an aesthetic problem for many patients, which can definitely affect their psychosocial behavior.
Gingival hyperpigmentation is not a condition and can be defined as " a darker gingival color beyond what is normally expected". Moreover, it can be attributed to multiple external or internal factors. It may be physiological (excessive melanin deposition) or pathological (smoking).
Gingival Depigmentation can be treated by different modalities including chemical and surgical methods. Lately, gingival Depigmentation was carried out by lasers, cryosurgery and radiosurgery.
Additionally, multiple evidence have suggested the use of ascorbic acid (vitamin C) to treat gin- gival pigmentation. It was demonstrated that ascorbic acid is a water-soluble antioxidant and an essential nutrient for collagen biosynthesis. Furthermore, it was proven that it is effective in the elimination of hyperpigmented lesion.
Lately, glutathione has come into focus in aesthetics because of its antimelanogenic (inhibits melanosome transfer from melanocytes to keratinocytes) and antioxidant properties. It aids in skin lightening because it inhibits tyrosinase enzymes. Moreover, the use of vitamin C and glutathione has been well established, as they participate in antioxidant cellular defense systems. The series of oxidation-reduction reactions that allow vitamin C and glutathione to interact each other makes them unique The aim of the current study is to evaluate the efficacy of its rather-epidermal vitamin C in conjunction with glutathione injection compared to the conventional surgical technique in order to manage patients with gingival hyperpigmentation.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Nourhan A Abdelkhalek
- 전화번호: 01005802478
- 이메일: naa14@fayoum.edu.eg
연구 장소
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Faiyum Governorate
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Al Fayyum, Faiyum Governorate, 이집트, 63511
- 모병
- Faculty of Dentistry
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연락하다:
- Amr E Emaraa, Associate professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
The selection criteria were done according to Gingival pigmentation index is as follows (Dummett and Bolden)10:
- Score0:absence of pigmentation
- Score1:spotsofbrowntoblackcolororpigments
- Score2:browntoblackpatchesbutnotdiffusepigmentation
- Score3:diffuse brown to black pigmentation,marginal,and attached.
Patients who have Dummett and Bolden index score 1, 2, or 3 will be included in addition to the following criteria:
- above 18yrs
- systemically free
- physiologic gingival hyperpigmentation related to esthetic region
- well maintained oral hygiene and willing to undergo minor surgical procedures
Exclusion Criteria:
- systemic diseases associated with pathological hyperpigmentation or improper delayed wound healing (uncontrolled diabetes, autoimmune diseases, etc.)
- pregnant and lactating mothers
- usage of chlorhexidine or povidone iodine
- Local causes (smoking)
- periodontal diseases (plaque and non-plaque induced gingivitis or periodontitis)
- non compliant patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Arm1:(Vit C & glutathione injection)
The site of interest will be anesthetized using topical anesthetic agent (lignocaine gel or xylocaine gel). Infiltration anesthesia will be recommended during the first injection visit. Intraepidermal injection of 1-1.5 ml of vitamin C and glutathione will be performed. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (50 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C & glutathione will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Maximum 0.1 ml of injection is recommended for each point with 2-3 mm apart. The same dose will be repeated once per week for maximum 4 visits till no further color improvement gained. |
Vitamins c and glutathione injection that usually used for cosmetic skin care (whitening)
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활성 비교기: ATM 2: surgical depigmentation
Using a 15c blade an epithelial layer and part of connective tissue will be removed till the pigmentation disappears with ultra care not to expose the bone. The marginal and interdental papillary tissues remain critical regions, fortunately, they are not deeply pigmented. Periodontal dressing is recommended for minimal 7 days postoperative. Patients will be instructed to avoid the mechanical trauma to the treated sites. Patients will be administering an analgesic (Ibuprofen 400 mg) to be used as needed. Following each injection visit, the patients will be asked to abstain from mechanical oral hygiene procedures in relation to the target region for the day of procedure only. Plain tooth pastes (Colgate toothpaste) with anti- inflammatory mouthwash (Citrolin mouth, Pharco Company, Egypt) were recommended. |
Removal of gingival pigmentation by scalpel
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)
기간: baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
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Degree of gingival pigmentation 0: no pigmentation
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baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
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Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)
기간: The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.
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Score 0: absence Score 1: spots of brown to black Score 2: brown to black patches but not diffuse Score 3: diffuse brown to black pigmentation
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The color assessment will be evaluated in the daylight and by examining the regular digital photographs which will be taken pre-operative (day of the procedure / day 1), and post-operatively after 1 month and 9 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain score
기간: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
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VAS scores pain will be divided into ten numerical parts consisting of one cm each on a horizontal line with two endpoints (left and right), with "0" representing "no pain" to "10" representing "severe pain."
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visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
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Itching
기간: visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
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A vertical scale for wound itching was measured with a scale with five scores: no itching (0) mild itching (1point) moderate itching (2 points) severe itching (3 points) extremely severe (4 points)
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visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
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Patient satisfaction
기간: At the end of the follow up period ( 9 months)
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using a 5- graded self-assessment analysis (Huh et al. 2003).
excellent (grade 4: improved over 75%) good (grade 3: improved 50e75%) moderate (grade 2: improved 25e50%) fair (grade 1: improved less than 25%) no change or worse (grade 0: not improved or darkened)
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At the end of the follow up period ( 9 months)
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Nourhan A Abdullah, Phd, Lecturer at faculty of dentistry, Fayoum university
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00012891#159
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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글루타티온에 대한 임상 시험
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Qualia Life Sciences아직 모집하지 않음
Vitamin c and glutathione에 대한 임상 시험
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus모병
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