Volumetric comparison of soft tissue around PEEK healing abutments vs standard healing abutments for single posterior implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial compares two implant prosthetic pathways: a test using a PEEK anatomic healing abutment and a control using a standard healing abutment, to restore a single missing posterior tooth. The study focuses on peri-implant soft tissue contours and overall health, employing volumetric analysis to quantify tissue changes. Eligible participants have a single missing posterior tooth, adequate bone and soft tissue dimensions, and good oral hygiene, and will undergo digital workflow steps to fabricate and place the restoration. Outcomes include soft tissue volume and integration with the prosthesis, with attention to simplifying the impression/scan process and preserving mucosal integrity. The trial aims to determine if the PEEK abutment can better maintain peri-implant mucosa during restoration.

Why it matters

Who can join: the full rules

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

Where it's running

• Universiti Teknologi MARA
  Sungai Buloh, Selangor, Malaysia Recruiting

Study contacts

• Study coordinator: Nur Hafizah Kamar Affendi, master
• Email: hafizah_kamar@uitm.edu.my
• Phone: +60361266545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.