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Peri-Implant HealthanatomicNCT07624331

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

A study testing AHA PEEK and standard healing abutment in people with Peri-Implant Health and Peri-Implant Tissues, run by DR NUR HAFIZAH KAMAR AFFENDI at 1 site in Malaysia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
AHA PEEK and standard healing abutment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteMalaysia
Study dates
23 May 2026to 1 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nur Hafizah Kamar Affendi, master contact

+60361266545

hafizah_kamar@uitm.edu.my

NORWATI Atikah Mustafa, phd contact

0361266545

norwati_atikah@uitm.edu.my

Malaysia1 site, 1 recruiting
  • Universiti Teknologi MARA

    Sungai Buloh, Selangor, 42300

    NUR HAFIZAH AFFENDI, MASTER, 0361266545, hafizah_kamar@uitm.edu.my

    nfizakama@gmail.com

    Recruiting

Other trials in Malaysia

About this study

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).

Read the 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.

Being tested
AHA PEEK, standard healing abutment
Keywords
Peri-Implant Tissues, volumetric analysis, soft tissue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AHA PEEKDevice

    polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment

  • standard healing abutmentDevice

    Titanium healing abutment

Study groups in NCT07624331
Study groupRoleWhat they receive
Group A: ControlPlacebo comparatorMonolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body
Receives: Device: standard healing abutment
Group B: PEEK AHAActive comparatorMonolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow
Receives: Device: AHA PEEK

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. volumetric soft tissue analysis

    Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading

    Measured: 12 months

Secondary outcomes (1)
  1. volumetric analysis changes

    Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start23 May 2026 (estimated)
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a prospective, open label, randomized, parallel double arm study for subject in need for dental implant in the posterior mandible with BLX Implant. The group allocation will be as follows: Group A: Control (Participant will received implant supported restoration conditioned with standard healing abutment and fabricated with standard scan body) Group B: Test (Participant will received implant supported restoration conditioned with PEEK anatomic healing abutment)
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07624331
Sponsor's protocol ID
REC/11/2025 (ST/FB/28)
Other IDs
Study IIS 26/25
Acronym
anatomic
Status last verified
May 2026
First submitted
22 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In in the agreement with Institute of Straumann AG

Questions about this trial

What is this clinical trial studying?

A study testing AHA PEEK and standard healing abutment in people with Peri-Implant Health and Peri-Implant Tissues, run by DR NUR HAFIZAH KAMAR AFFENDI at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nur Hafizah Kamar Affendi, master (+60361266545, hafizah_kamar@uitm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volumetric soft tissue analysis (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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