RecruitingNot ApplicableNCT07624331
Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations
Sponsor
DR NUR HAFIZAH KAMAR AFFENDI
Enrollment
38 participants
Start Date
May 23, 2026
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria9
- 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
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Interventions
DEVICEAHA PEEK
polyetheretherketone (PEEK) anatomic healing abutment versus standard anatomic healing abutment
DEVICEstandard healing abutment
Titanium healing abutment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07624331
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