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

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).

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Augmentation at Dental Implants; Peri-Implant Health; Peri-Implant Tissues
• Intervention / Treatment: Device: standard healing abutment; Device: AHA PEEK

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nur Hafizah Kamar Affendi, master; Phone Number: +60361266545; Email: hafizah_kamar@uitm.edu.my
• Study Contact Backup: Name: NORWATI Atikah Mustafa, phd; Phone Number: 0361266545; Email: norwati_atikah@uitm.edu.my

Study Locations

• Malaysia
  • Selangor
    • Sungai Buloh, Selangor, Malaysia, 42300
      • Recruiting
      • Universiti Teknologi MARA
      • Contact: NUR HAFIZAH AFFENDI, MASTER; Phone Number: 0361266545; Email: hafizah_kamar@uitm.edu.my
      • Contact: Email: nfizakama@gmail.com
      • Principal Investigator: Nur Hafizah Kamar Affendi, MASTER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A: Control; Monolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body	Device: standard healing abutment; Titanium healing abutment
Active Comparator: Group B: PEEK AHA; Monolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow	Device: AHA PEEK; polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volumetric soft tissue analysis	Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volumetric analysis changes	Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic White Esthetic Score	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

Collaborators and Investigators

• Sponsor: DR NUR HAFIZAH KAMAR AFFENDI
• Investigators: Study Director: Professor Dr Mohd Yusmiaidil Putera Mohd Yusoff, phd, Universiti Teknologi MARA

Study record dates

Study Major Dates

• Study Start (Estimated): May 23, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: volumetric analysis; soft tissue; Peri-Implant Tissues
• Other Study ID Numbers: REC/11/2025 (ST/FB/28); Study IIS 26/25 (Other Grant/Funding Number: INVESTIGATOR INITIATED STUDIES (IIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In in the agreement with Institute of Straumann AG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No