Apically Positioned Flap vs Rolled Flap for Soft Tissue Management During Implant Second-Stage Surgery
2026年5月12日 更新者：Ohio State University
Peri-Implant Soft Tissue Management During Second-Stage Surgery With Two Different Flap Techniques: A Randomized Controlled Study
Patients are being asked to consider joining a research study that looks at two different ways dentists uncover dental implants during a small gum surgery. To join this study, Patients must have two dental implants that are ready to be uncovered. Both uncovering methods used in this research are normal, safe procedures that dentists already use every day. The purpose of this study is to learn which method helps the gums heal better, stay thicker, and look more natural over time.
If patients decide to participate, the dentist will use one method on one implant and the other method on the second implant so we can compare how each implant heals. The study lasts about one year and includes the uncovering surgery plus scheduled follow-up visits. At these visits, the dentist will gently measure your gums, take pictures, take routine dental X-rays, and use a small camera scanner to check how the gum tissue changes. Patients will also be asked to rate any pain or swelling after surgery.
Patients may have soreness, swelling, or minor bleeding-these are the same risks patients would have during normal implant care. Patients may or may not personally benefit, but the extra monitoring may help us track the healing closely, and patients' participation can help dentists improve care for future patients.
Patients can receive regular implant treatment without joining the study. The goal of this summary is to help you think about the pros and cons and decide what feels right for patients.
調査の概要
研究の種類
介入
入学 (推定)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Olivia Bodnar, DDS
- 電話番号：6142924641
- メール：bodnar.61@buckeyemail.osu.edu
研究連絡先のバックアップ
- 名前：Guo-Liang Cheng, DDS, MS
- 電話番号：6142924641
- メール：cheng.712@osu.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Patients between the ages of 18-80.
- Non-smokers or former smokers with at least a 5-year successful cessation history.
- Patients with normal systemic health (ASA-I) or well-controlled/stable systemic conditions (ASA-II), such as diabetes with HbA1c < 7.0%, no recent acute myocardial infarction or cerebrovascular accidents within 6 months, or any contraindication for periodontal or implant surgery.
- Patients who had, or plan to have, 2 non-adjacent implants of the same system placed under a two-stage implant protocol.
- The diameter discrepancy of the 2 target implants must be less than 1 mm.
Exclusion Criteria:
- Current smokers, or smokers who have quit <5 years prior to study entry.
- Pregnant or lactating women
- Patients with substance or alcohol abuse
- Patients with a history of antiresorptive therapy, head and neck radiotherapy, and chemotherapy for malignant tumors
- Other systemic conditions or medication affecting wound healing.
- Poor plaque control with plaque score > 20%
- Active/untreated odontogenic and periodontal infections
- Implants placed, or planned to be placed, with one-stage implant protocol.
- The diameter discrepancy of the 2 target implants is equal to or greater than 1 mm (≥ 1 mm).
- Implants showing signs of early peri-implant bone loss or infection.
- Severe loss of keratinized tissue (> 50%) at the implant site
- Non-English speaking individuals for studies involving informed consent.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：トリプル
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：Apically Positioned Flap (APF)
During implant second-stage surgery, a crestal incision with vertical releases is used to elevate a flap that is repositioned apically and buccally to increase the width of keratinized tissue around the implant, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a crestal incision with vertical releases is performed, and the flap is repositioned apically and buccally to increase the width of keratinized tissue around the implant.
|
|
実験的：Rolled Flap Technique (RFT)
During implant second-stage surgery, a full-thickness flap is elevated, and a pedicled connective tissue portion is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness, followed by placement of a healing abutment and suturing.
|
A flap design used during implant second-stage surgery in which a pedicled connective tissue portion of the flap is de-epithelialized and rolled toward the buccal aspect to increase peri-implant soft tissue thickness.
|
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 Keratinized Tissue Width
時間枠：Baseline (second-stage surgery) to 12 months after surgery
|
Keratinized tissue width will be measured clinically in millimeters at the mid-buccal aspect of the implant using a periodontal probe at prespecified follow-up visits.
|
Baseline (second-stage surgery) to 12 months after surgery
|
|
Change in Peri-Implant Mucosal Thickness
時間枠：Baseline (second-stage surgery) to 12 months after surgery
|
Peri-implant mucosal thickness will be assessed by superimposing serial intraoral scan data to quantify changes in buccal soft tissue thickness at implant sites over time.
|
Baseline (second-stage surgery) to 12 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pink Esthetic Score (PES)
時間枠：3, 6, and 12 months after second-stage surgery
|
Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score based on standardized clinical photographs, assessing papilla, tissue contour, color, and texture.
|
3, 6, and 12 months after second-stage surgery
|
|
Change in Peri-Implant Soft Tissue Volume
時間枠：Baseline to 3, 6, and 12 months after second-stage surgery
|
Three-dimensional soft tissue volume changes will be quantified by superimposing serial intraoral scan data obtained at baseline and follow-up visits.
|
Baseline to 3, 6, and 12 months after second-stage surgery
|
|
Early Wound Healing Index
時間枠：1 and 2 weeks after second-stage surgery
|
Early wound healing will be assessed using a standardized healing index based on tissue color, bleeding, granulation tissue, and epithelialization.
|
1 and 2 weeks after second-stage surgery
|
|
Plaque Index (PI)
時間枠：1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Oral hygiene status will be assessed using the plaque index based on clinical examination at peri-implant sites.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
|
Modified Sulcular Bleeding Index (mSBI)
時間枠：1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
Peri-implant soft tissue inflammation will be assessed using the modified sulcular bleeding index during clinical examination.
|
1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after second-stage surgery
|
|
Postoperative Pain Score
時間枠：1 and 2 weeks after second-stage surgery
|
Participant-reported pain will be measured using a visual analog scale (VAS, 0-100), where higher scores indicate greater pain intensity.
|
1 and 2 weeks after second-stage surgery
|
|
Postoperative Swelling Score
時間枠：1 and 2 weeks after second-stage surgery
|
Participant-reported swelling will be assessed using a visual analog scale (VAS, 0-100), where higher scores indicate greater perceived swelling.
|
1 and 2 weeks after second-stage surgery
|
|
Change in Peri-Implant Bone Level
時間枠：Baseline to 12 months after second-stage surgery
|
Peri-implant marginal bone levels will be assessed using standardized periapical radiographs and compared between baseline and follow-up.
|
Baseline to 12 months after second-stage surgery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月30日
一次修了 (推定)
2028年6月30日
研究の完了 (推定)
2028年6月30日
試験登録日
最初に提出
2026年5月12日
QC基準を満たした最初の提出物
2026年5月12日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月12日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY20252723
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?
未定
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。