Gingival Hyperpigmentation Treatment
Gingival Hyperpigmentation Treatment With Injectable Vitamin C in Conjunction With Glutathione Versus The Conventional Surgical Depigmentation: A Randomized Controlled Clinical Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Nourhan A Abdelkhalek
- 電話番号：01005802478
- メール：naa14@fayoum.edu.eg
研究場所
-
-
Faiyum Governorate
-
Al Fayyum、Faiyum Governorate、エジプト、63511
- 募集
- Faculty of Dentistry
-
コンタクト：
- Amr E Emaraa, Associate professor
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：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)
|
|
アクティブコンパレータ：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
|
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 |
|---|---|---|
|
Degree of gingival pigmentation by Takashi index (Hanioka et al., 2005)
時間枠：baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
|
Degree of gingival pigmentation 0: no pigmentation
|
baseline: before surgery/injection (day1), after 1 mon ,3 mon ,6 mon and 9 month
|
|
Degree of gingival pigmentation by Gingival pigmentation index (Kumar et al., 2013)
時間枠：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.
|
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
|
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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain score
時間枠：visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
|
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."
|
visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
|
|
Itching
時間枠：visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
|
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)
|
visual analogue scale (VAS) after the surgery/injection (day 1) till 10 days after (day 10 after the surgery/injection)
|
|
Patient satisfaction
時間枠：At the end of the follow up period ( 9 months)
|
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)
|
At the end of the follow up period ( 9 months)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nourhan A Abdullah, Phd、Lecturer at faculty of dentistry, Fayoum university
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00012891#159
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。