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Guided Modified Socket Shield With Hyaluronic Acid for Black Triangle Management

2026年5月13日 更新者:Walid Elamrousy、Kafrelsheikh University

Hyaluronic Acid With AI-Guided Immediate Implant Placement Using a Modified Socket Shield for Black Triangle Management: A Randomized Controlled Clinical Trial

The Primary aim of this study will be to evaluate the clinical, esthetic, and radiographic outcomes of hyaluronic acid combined with immediate implant placement using AI-assisted and computer guided modified socket shield technique in maxillary anterior sites exhibiting black triangles.

調査の概要

詳細な説明

The growing patient demand for quicker aesthetic solutions has led oral implantologists to adopt more immediate protocols compared to the delayed approach originally recommended by Brånemark. Studies have shown that implants placed immediately after atraumatic extraction can achieve success rates comparable to those placed in healed sockets. Other findings reported favorable results with immediate implant placement, including reduced resorptive bone changes post-extraction.

Following extraction, the alveolar ridge undergoes changes that often result in bone loss. This is mainly due to the elimination of periodontal ligament attachments and trauma during extraction, with the buccal bone plate being especially affected. Retaining part of the root has been shown to help preserve bone in pontic areas. In 2010, Hürzeler et al. introduced the socket shield technique to mitigate post-extraction bone loss by maintaining the labial portion of the root. Their results indicated stabilized buccal bone height.

Multiple modifications of the socket shield technique have since emerged. Modified socket shield technique (MSST), that involved thinning the labial shield to 1.5 mm, keeping it at the crest level, and leaving the space (jumping gap) between implant and shield without grafting . Some studies highlight the role of grafting this gap in achieving better outcomes. A histological investigation in sheep compared bone healing with and without grafting and found that although bone formed in both cases, the ungrafted bone was structurally weak and had fewer trabeculae, making it unsuitable for supporting masticatory loads.

Human histology showed that this gap could allow soft tissue ingrowth. Currently, there is no definitive human research proving the necessity of grafting in this context. Therefore, Gluckman emphasized the need for further clinical studies to evaluate the benefits of grafting the jumping gap in the MSST protocol.

Artificial intelligence (AI) has transformed digital planning and clinical execution in implant dentistry. AI-based tools analyze CBCT data, segment anatomical structures, identify vital landmarks, and simulate prosthetically driven implant positions with high accuracy. AI can improve implant positioning, angulation, depth control, and proximity to anatomical structures. It reduces surgical errors and improves long-term outcomes.

AI also enables precision in guide design and improves the predictability of immediate implant protocols. In esthetically demanding cases, such as those involving anterior maxillary implants, AI enhances decision-making and reduces clinician variability. It further allows prediction of soft and hard tissue changes through machine learning models trained on clinical imaging data.

In compromised situations, such as periodontally involved teeth, AI supports better planning by incorporating bone quality, defect morphology, and risk factors into surgical execution . It can detect critical patterns in bone loss, root anatomy, and soft tissue contours, guiding shield design and implant orientation.

Implant placement in sites previously affected by periodontitis poses risks. These sites often present with reduced bone volume, loss of papilla, apical migration of soft tissue, and compromised blood supply. Residual periodontal pathogens and altered healing responses make these areas less predictable for osseointegration.

Immediate implant placement in such sites requires careful evaluation. Inadequate primary stability and poor soft tissue support increase implant failure risk. Using guided protocols, with the support of AI and advanced techniques like root shielding, can help reduce complications. Maintaining remaining structures and optimizing healing are critical in these patients.

Reconstructing the interdental papilla remains one of the most demanding aesthetic challenges in periodontology. The interdental papilla contributes not only to appearance but also to function. It also plays a protective role for the periodontium by preventing debris accumulation. Black triangles may develop. These can result from aging, tooth shape, or periodontal conditions.

Over the years, several surgical strategies, such as coronally advanced flaps or subepithelial connective tissue grafts, have been proposed. These interventions often yield inconsistent outcomes due to limited blood flow and the small size of the papillary area. ] Recently, non-surgical techniques have gained attention for papilla reconstruction. These include prosthetic adjustments, restorative procedures, and orthodontic interventions. One minimally invasive option is the injection of hyaluronic acid gel (HA) to restore lost interdental papilla between teeth or implants. This approach is considered safe and shows promising outcomes. HA is a naturally found linear polysaccharide in the extracellular matrix and exists in gingival tissues and the periodontal ligament. Its clinical effect usually lasts between 6 and 12 months.

Due to its hygroscopic properties, HA contributes to lubrication, volume maintenance, protein exclusion, and shock absorption in papillary gaps. It also supports wound healing, tissue repair, and the structural balance of periodontal tissues.

As far as the authors are aware, this is the first study utilizing socket shield approach in periodontally compromised sites & the first study that combines AI assisted and computer guided socket shield with HA in periodontally compromised sites in anterior esthetic zone.

研究の種類

介入

入学 (推定)

32

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

研究連絡先のバックアップ

研究場所

    • Kafrelsheikh
      • Kafr ash Shaykh、Kafrelsheikh、エジプト、214312
        • Faculty of Dentistry, Kafrelsheikh University

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

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Adults (20-50) years old.
  • Single rooted maxillary anterior teeth with hopeless prognosis.
  • Periodontally compromised but with >50% remaining bone.
  • Presence of black triangle ≥2 mm.
  • Systemically healthy.

Exclusion Criteria:

  • Medically compromised patients and systemic conditions that complicate implant placement as uncontrolled diabetes, osteoporosis.
  • Alcoholic and Smokers patients.
  • Pregnant or lactating women.
  • Acute Pathology or infection at implant site
  • Patients with a history of chemotherapy, radiotherapy in head and/or neck region.
  • Patients on bisphosphonate or steroids therapy.

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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Flapless Socket shield technique with AI-based immediate implant placement
The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement
Computer guided socket shield with immediate implant placement
実験的:Flapless Socket shield technique with AI-based immediate implant placement & Hyaluronic Acid
The root was vertically sectioned with removal of the palatal fragment and preservation of a 2 mm buccal shield shaped and beveled to support the emergence profile. Guided osteotomy was performed followed by immediate implant placement then 0.2 mL of hyaluronic acid was injected into the interproximal papillary area
Computer guided socket shield with immediate implant placement with papilla injection by 0.2 mL of hyaluronic acid

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
Interproximal papilla fill
時間枠:12-months
Using digital photographs the fill of interdental papilla will be assessed
12-months

二次結果の測定

結果測定
メジャーの説明
時間枠
pink esthetic score
時間枠:12-months
The Pink Esthetic Score (range: 0-14) was assessed based on digital intraoral photographs by assigning a score of 0 to 2 for the following criteria compared to the adjacent reference tooth: mesial and distal papillae, soft tissue color, texture, level, contour, and alveolar bone defect
12-months

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

捜査官

  • スタディチェア:Ahmed abdelmonem, bachelor、faculty of dentistry, Tanta university

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5月10日

一次修了 (推定)

2027年6月10日

研究の完了 (推定)

2027年6月15日

試験登録日

最初に提出

2026年5月8日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15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13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

  • OMPDR4-26/3575

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?

いいえ

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いいえ

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いいえ

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