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

NCT07624331 | Recruiting

• 2 other identifiers: REC/11/2025 (ST/FB/28)Study IIS 26/25
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peri-Implant Health; Peri-Implant Tissues; Soft Tissue Augmentation at Dental Implants

Keywords

Peri-Implant Tissues; volumetric analysis; soft tissue

Outcome Measures

Primary Outcomes (1)

• volumetric soft tissue analysis

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

  12 months

Secondary Outcomes (1)

• volumetric analysis changes

  12 months

Other Outcomes (1)

• Pink Esthetic White Esthetic Score

  12 months

Study Arms (2)

Group A: Control

PLACEBO COMPARATOR

Monolithic zirconia screw retained crown conditioned with titanium standard healing abutment (SHA) and fabricated with standard monoscan body

Device: standard healing abutment

Group B: PEEK AHA

ACTIVE COMPARATOR

Monolithic zirconia screw retained crown conditioned and fabricated with AHA digital workflow

Device: AHA PEEK

Interventions

AHA PEEK DEVICE

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

Group B: PEEK AHA

standard healing abutment DEVICE

Titanium healing abutment

Group A: Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DR NUR HAFIZAH KAMAR AFFENDI: lead

Study Sites (1)

Universiti Teknologi MARA

Sungai Buloh, Selangor, 42300, Malaysia

RECRUITING

Study Officials

• Professor Dr Mohd Yusmiaidil Putera Mohd Yusoff, phd

  Universiti Teknologi Mara

  STUDY DIRECTOR

Central Study Contacts

Nur Hafizah Kamar Affendi, master

CONTACT

+60361266545; hafizah_kamar@uitm.edu.my

NORWATI Atikah Mustafa, phd

CONTACT

0361266545; norwati_atikah@uitm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: yes, co investogator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Prof

Model Details: This is a prospective, open label, randomized, parallel double arm study for subject in need for dental implant in the posterior mandible with BLX Implant. The group allocation will be as follows: Group A: Control (Participant will received implant supported restoration conditioned with standard healing abutment and fabricated with standard scan body) Group B: Test (Participant will received implant supported restoration conditioned with PEEK anatomic healing abutment)

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 3, 2026
• Study Start: May 23, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)