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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDR NUR HAFIZAH KAMAR AFFENDI

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • AHA PEEK

    Device

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

  • standard healing abutment

    Device

    Titanium healing abutment

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Group A: ControlPlacebo comparator 1 intervention
Group B: Group B: PEEK AHAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

volumetric soft tissue analysis

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

Time frame
12 months

Secondary outcomes

1

volumetric analysis changes

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

Time frame
12 months

Other outcomes

1

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.

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DR NUR HAFIZAH KAMAR AFFENDI

Lead sponsor

Universiti Teknologi Mara

Sponsor institution