Actively Recruiting
Volumetric Analysis of Soft Tissue Changes Between PEEK Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations
Led by DR NUR HAFIZAH KAMAR AFFENDI · Updated on 2026-06-03
38
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the effects of implant crowns made with either a standard scan body or a polyetheretherketone (PEEK) anatomic healing abutment (AHA) in patients needing a single posterior tooth implant. The study focuses on how well these two methods preserve soft tissue around the implant and aims to improve the accuracy and comfort of dental implant restorations. It also evaluates patient outcomes related to these two different digital impression workflows. Participants will receive one of two treatments: a monolithic zirconia screw-retained crown made using a standard titanium healing abutment with a standard scan body, or a similar crown made using the PEEK anatomic healing abutment digital workflow. The PEEK abutment allows for digital impressions without removing the healing abutment, potentially reducing soft tissue collapse and chairside time. Each participant is randomly assigned to one of these two groups to compare the outcomes. Throughout the study, participants will have their peri-implant soft tissue changes measured using volumetric analysis over 12 months. Researchers will assess tissue stability before and after crown delivery, esthetic scores, keratinized mucosa width, papilla height variation, and patient-related outcomes. The study includes regular evaluations to monitor these factors and ensure safety, with total participation lasting at least 12 months to observe both immediate and longer-term effects.
CONDITIONS
Brief Title
Volumetric Analysis of Peri-Implant Soft Tissue Changes Between Polyethereketone(PEEK) Anatomic Healing Abutments and Standard Healing Abutments in Posterior Single Implant Restorations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Legally competent to provide written informed consent
- Adults aged 18 years or older
- Requires replacement of a single missing posterior tooth with mesiodistal dimension of at least 8 mm
- Intact adjacent teeth on both sides with an existing opposing tooth
- Good oral hygiene with plaque score less than 25%
- Adequate keratinized mucosa width of at least 6 mm at the edentulous site
- Adequate bone volume for implant placement (5.5 mm diameter, 10 mm length) confirmed by CBCT
- Adequate interocclusal distance of at least 6 mm from alveolar crest to occlusal table
You will not qualify if you...
- Presence of localized or generalized periodontitis
- Active acute infection
- History of malignancy, radiotherapy, or chemotherapy
- Bone metabolic diseases or current medications affecting bone metabolism
- Untreated bruxism or parafunctional habits
- Severe occlusal discrepancy
- Medical conditions contraindicating implant placement or causing severe daily activity impairment (ASA III or higher)
- Need for bone grafting at the implant site
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive implant placement followed by either a standard titanium healing abutment or a polyetheretherketone (PEEK) anatomic healing abutment. The treatment involves digital impressions and restoration with a monolithic zirconia screw retained crown using the assigned healing abutment.
Multiple visits for implant placement, digital impression, and crown delivery
Duration - Up to 12 months
Participants are monitored for peri-implant soft tissue stability, volumetric soft tissue changes, aesthetic outcomes, and patient-reported outcomes following crown delivery.
Periodic visits for assessment over 12 months
Trial Site Locations
Total: 1 location
1
Universiti Teknologi MARA
Sungai Buloh, Selangor, Malaysia, 42300
Actively Recruiting
Research Team
N
Nur Hafizah Kamar Affendi, master
N
NORWATI Atikah Mustafa, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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