Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 groups that differ only in the material that will be used at the graft site:
- Gum tissue taken from the patient's own palate (standard of care group)
- Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study).
Both materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study.
Participants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.
調査の概要
詳細な説明
The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate (standard of care) or commercially available tissue called a "collagen matrix" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.
Teeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing/flossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. "Gum grafting" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Angela Palaiologou-Gallis, DDS
- 電話番号：210-567-3567
- メール：palaiologouA@uthscsa.edu
研究連絡先のバックアップ
- 名前：Brian L Mealey, DDS, MS
- 電話番号：210-567-3589
- メール：mealey@uthscsa.edu
研究場所
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-
Texas
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San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center at San Antonio School of Dentistry
-
コンタクト：
- Brian L Mealey, DDS, MS
- 電話番号：210-567-3318
- メール：mealey@uthscsa.edu
-
コンタクト：
- Angela Palaiologou-Gallis, DDS
- 電話番号：210-567-3589
- メール：palaiologouA@uthscsa.edu
-
-
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:
- Male or female patient aged 18 to 89
- One or more teeth/dental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT
- A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.
- Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day).
Exclusion Criteria:
- Patients with a known allergy to collagen of animal origins.
- Patients who will not cooperate with the follow-up schedule.
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)
- Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- Patients with active or systemic infections other than periodontitis; a disease entity, condition or therapeutic regimen which decreases probability of soft tissue healing, e.g., poorly controlled diabetes, autoimmune diseases, long-term steroid therapy.
- Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)
- People who live more than 50 miles from the UTSA School of Dentistry are not eligible.
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 |
|---|---|
|
アクティブコンパレータ：Test Group Porcine Collagen Matrix
The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
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The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
|
|
介入なし：Control Group - Palatal Graft
The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented
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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 |
|---|---|---|
|
Change in width of Keratinized Tissue
時間枠：Baseline to 6 months
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The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.
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Baseline to 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Graft dimension width change
時間枠：Baseline to 6 months
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Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)
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Baseline to 6 months
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Graft Length Change
時間枠：Baseline to 6 months
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Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft length (horizontal dimension).
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Baseline to 6 months
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Dimensional area change
時間枠：Baseline to 6 months
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Dimensional change of the grafted area during healing will be assessed by endpoints of graft width (vertical dimension), graft length (horizontal dimension) to measure graft area.
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Baseline to 6 months
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Length of surgery in minutes
時間枠：Time to complete surgery (approximately 2-3 hours)
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The length of surgery in minutes will be assessed by use of a standard timer.
The timer will start when the first incision is made.
The timer will stop 3 minutes after the final suture is placed and pressure has been applied at the recipient surgery site.
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Time to complete surgery (approximately 2-3 hours)
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Numerical rating score for color match
時間枠：One month to 6 months
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A 21-point numerical rating scale (NRS-21) with which patients and clinicians can assess color match of the grafted area to the surrounding soft tissue.
The NRS-21 scale allows scores ranging from 0 (worst color match) to 10 (best color match) in increments of 0.5.
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One month to 6 months
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Pain Score on Numeric Rating Scale (NRS)
時間枠：24 to 168 hours after surgery
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Pain associated with the surgery will be assessed by patients using NRS-21 that ranges from 0 to 10 in 0.5 increments, with 0 indicating no pain and 10 indicating intolerable pain.
Patients will record NRS-21 scores on paper forms
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24 to 168 hours after surgery
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Analgesic consumption
時間枠：24 to 168 hours
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Participants will count and document number of analgesics (ibuprofen and acetaminophen) taken after surgery
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24 to 168 hours
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San Antonio Texture index (SaTi)
時間枠：One month to six months
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A 4-point texture index score for clinicians to assess the tissue texture match of the grafted area to the surrounding soft tissue. The SATi is a four-point rating scale as follows:
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One month to six months
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協力者と研究者
捜査官
- 主任研究者：Brian L Mealey, DDS, MS、The University of Texas Health Science Center at San Antonio
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
- STUDY00002814
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国で製造され、米国から輸出された製品。
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