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Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations (anatomic)

2026年5月31日 更新者:DR NUR HAFIZAH KAMAR AFFENDI
This prospective randomized clinical trial will evaluate the clinical outcomes of the implant crown fabricated with standard scan body (control) and polyetheretherketone (PEEK) anatomic healing abutment (test).

調査の概要

詳細な説明

In recent decades, implant supported restorations have evolved into a well-established therapeutic option for restoring a single missing tooth. One of the key factors contributing to their success is the presence of a well-contoured prosthesis that closely mimics the morphology of adjacent teeth. In addition, the restoration must support the health of hard and soft tissues surrounding the peri-implant mucosa. To replicate the peri-implant soft-tissue contour, the conventional workflow employs an analog impression protocol, which may prone to deformation caused by dimensional changes in impression materials or dental stone. This process also requires longer chairside time and may cause patient discomfort. Considering these limitations, digital impressions obtained using intraoral scanners have been introduced to address these challenges .

With advances in computer-aided design and manufacturing (CAD/CAM), the workflow to fabricate implant restorations is commonly carried out using scan body. Once the implant has osseointegrated, the routine clinical protocol involves disconnection of the titanium standard healing abutment,followed by scanning the scan body , peri-implant mucosa contour, the antagonist arch, and occlusal registration. This workflow, however, requires repeated component disconnections, which may lead to peri-implant mucosal collapse and inaccuracies in soft tissue profile replication. Furthermore, the use of standard healing abutment size often creates a circular soft tissue contour, resulting in an unfavourable emergence profile that may require additional surgery or recontouring. Therefore, reproducing the anatomy of the contralateral tooth with a well-contoured implant restorative emergence profile (IREP) is commonly recommended through the use of a custom healing abutment. Several methods have been introduced to fabricate customized healing abutments, including the chairside addition of flowable composite to temporary abutments. In addition, the computer-aided design and computer-aided manufacturing (CAD/CAM) socket seal abutment (SSA) has been proposed to preserve soft and hard-tissue dimensions following implant placement. This workflow includes an additional step of milling the SSA and cementing it to a temporary abutment during the same surgical appointment. However, this approach carries a risk of contamination and requires additional time and cost. Despite these developments, challenges remain with the current use of standard scan bodies. Most standard scan bodies have a conical or cylindrical shape that fails to replicate the natural morphology of a tooth, especially in posterior molar regions. Furthermore, regardless of the patient's gingival phenotype, peri-implant mucosal collapse occurs rapidly often within 20 seconds after losing the physical support following the removal of the customized healing abutment and insertion of the scan body.This soft tissue deviation may cause unstable mucosal margin and exert excessive pressure when delivering final implant restoration, often leading to additional chairside adjustments. To overcome the peri-implant soft tissue deviation and accurate replication, a novel anatomic healing abutment fabricated from polyetheretherketone (PEEK) has been introduced to capture digital impression without removing the healing abutment. This allows one-step formation of an emergence profile that mimics natural tooth anatomy and may reduce the chairside time. Utilizing a predefined emergence profile in the software library, the AHA eliminates the need for additional soft tissue modification, expedites the prosthetic workflow, and includes an identification code for accurate scanning. Despite these advantages, there is currently no clinical evidence validating the use of AHA for preserving peri-implant soft tissue, improving workflow efficiency, crown-fitting accuracy, or evaluating its impact on patientrelated outcomes. This warrants further investigation through controlled clinical evaluation. Therefore, this study aims to evaluate the dimensional changes of peri-implant soft tissue following implant placement in healed sites before and after crown delivery, to assess the immediate and time-dependent soft-tissue stability after standard healing abutment and AHA removal. Additionally, this study will compare the pink white esthetic score (PESWES) , keratinized mucosa width (KMW) , mesiodistal papilla height variation and patient-related outcomes of digital impression workflows using either a standard scan body or AHA for posterior single-implant restorations.

研究の種類

介入

入学 (推定)

38

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

    • Selangor
      • Sungai Buloh、Selangor、マレーシア、42300
        • 募集
        • Universiti Teknologi MARA
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Nur Hafizah Kamar Affendi, MASTER

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

はい

説明

Inclusion Criteria:

legally competent to provide written informed consent form prior to any study related procedures.

  • Subjects of either sex or aged 18 above
  • requires replacement of a single missing posterior tooth with adequate mesiodistal dimension (≥8 mm)
  • intact adjacent teeth on both sides with existing opposing tooth condition
  • good oral hygiene, plaque score <25% bpe1
  • adequate keratinized mucosa width (kmw) minimum 6 mm at the edentulous site
  • adequate bone volume to accommodate the planned dental implant placement of 5.5 mm diameter and 10 mm in length as verifified by Cone Beam Computed Tomography (CBCT)
  • adequate interoccusal distance (crown height space) of at least 6mm measured from alveolar crest to the occlusal table.

Exclusion Criteria:

Localized or generalized periodontitis

  • Presence of active acute infection
  • History of malignancy, radiotherapy or chemotherapy
  • Bone metabolic diseases (e.g.: osteogenesis imperfecta, Paget's disease) or current use of medications affecting bone metabolism
  • Untreated bruxism or parafunctional habits Docusign Envelope ID: FFD7C6C1-66CB-4359-9662-63230F769528 22
  • Severe occlusal discrepancy
  • Any medical condition contraindicating implant placement or alter daily activities to a level consistent with ASA (American Society of Anesthesiologist) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune or psychiatric disorders)
  • Subjects in need of bone grafting at the site of intended implantation site.
  • Subjects that are pregnant

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
プラセボコンパレーター:Group A: Control
Monolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body
Titanium healing abutment
アクティブコンパレータ:Group B: PEEK AHA
Monolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow
polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment

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
volumetric soft tissue analysis
時間枠:12 months
Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
volumetric analysis changes
時間枠:12 months
Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes
12 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Pink Esthetic White Esthetic Score
時間枠:12 months

The PES will be used to evaluate peri-implant soft tissue esthetics and will be assessed at 3 and 12 months after implant placement. PES includes seven parameters: mesial papilla, distal papilla, soft tissue level, soft tissue contour, root convexity, soft tissue color, and soft tissue texture. Each parameter is scored from 0 to 2, where 0 indicates an obvious discrepancy with the contralateral tooth, 1 indicates a minor discrepancy, and 2 indicates no discrepancy. The maximum possible PES is 14, with scores ≥8 considered esthetically acceptable and scores ≥12 indicating an excellent result. The WES will be used to evaluate the esthetic integration of the implant crown and will be assessed based on five parameters: tooth outline, volume, shade, surface texture, and translucency. Each parameter is scored from 0 to 2, following the same scoring criteria as PES.

The maximum WES is 10, with scores ≥6 considered esthetically acceptable.

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。

捜査官

  • スタディディレクター:Professor Dr Mohd Yusmiaidil Putera Mohd Yusoff, phd、Universiti Teknologi MARA

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23日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2028年10月1日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年5月31日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月3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31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

  • REC/11/2025 (ST/FB/28)
  • Study IIS 26/25 (その他の助成金/資金番号:INVESTIGATOR INITIATED STUDIES (IIS))

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

IPD プランの説明

In in the agreement with Institute of Straumann AG

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。

standard healing abutmentの臨床試験

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