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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
AHA PEEK
Devicepolyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment
standard healing abutment
DeviceTitanium healing abutment
Treatment groups
Trial outcomes
Primary outcomes
volumetric soft tissue analysis
Three-dimensional volumetric analysis changes at healed sites before implant placement and after implant crown loading
Secondary outcomes
volumetric analysis changes
Three-dimensional volumetric analysis changes of immediate and time-dependent peri-implant soft-tissue dimensional changes
Other outcomes
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.
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