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CompletedNCT07697066Updated Jul 10, 2026

Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile

An interventional study of Titanium healing abutment and Polyetheretherketone (PEEK) in Implant, Healing and Polyether Ether Ether Ketone, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

This study aimed to estimate the impact of various customized healing abutments materials on the peri-implant soft tissue profile

Read the detailed description

A dental implant is a method for the replacement of lost teeth, with an excellent prospering percentage plus lasting functional rehabilitation without requiring any preparation of the nearby teeth.

The usage of a healing abutment is one of the crucial clinical procedures that follows implant placement. It aids in establishing a stable and natural gingival emergence profile by supporting soft tissue shaping and shielding the implant platform. Various materials are available for healing abutments, which have an impact on biocompatibility, aesthetic results, soft tissue reaction, and patient comfort throughout the healing process.

Polyether ether ether ketone (PEEK) healing abutments are offering a non-metallic, lightweight option with a modulus of elasticity similar to bone, but they have lower surface hardness compared to titanium and zirconia, and long-term data is still developing.

3D printed hybrid resin materials were introduced earlier, allowing faster and precise fabrication of permanent dental restorations. P-Crown V4 material is a newly introduced 3D-printed nanoceramic-filled resin reported to contain up to 70% nanoceramic filler to enhance strength and hardness.

02

Conditions studied

  • Implant
  • Healing
  • Polyether Ether Ether Ketone
  • 3D Printed Hybrid Resin
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient's aged 25-45 years old
  • Patients with missing tooth needing solitary implant placement rehabilitation in the maxillary anterior regions with neighboring and opposite normal teeth.
  • Adequate mesial, distal, and interocclusal space for implant engagement and its absolute re-establishment.
  • Patients can recite and mark the informed approval paper.
  • Medically free patients or with controlled systemic disease.
  • Patients with acceptable bone quality and quantity.
  • Patients can return for follow-up examinations and evaluation.
  • Patients with good oral hygiene.
  • Nasal floor clearance from root apex at least 4 mm.

Exclusion criteria

Exclusion Criteria:

  • Patients with inappropriate implantation situates (patients with foremost bony deficiencies or sever bone resorption).
  • Patient with severe clenching or bruxism.
  • Heavy smokers or drug abusers.
  • Psychiatric complications or impractical prospects.
  • Patients with bad oral hygiene.
  • Systemic conditions that may impact soft or hard tissue curing.
  • Patients with history of radiation treatment in the head and neck area.
  • Pregnant female
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Group I

    Patients received a standard ready-made titanium healing abutment (control group).

    Procedure: Titanium healing abutment

  • Experimental
    Group II

    Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.

    Procedure: Polyetheretherketone (PEEK)

  • Experimental
    Group III

    Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.

    Procedure: 3D-printed hybrid resin (P crownV4)

Interventions

  • ProcedureTitanium healing abutment

    Patients received a standard ready-made titanium healing abutment (control group).

  • ProcedurePolyetheretherketone (PEEK)

    Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.

  • Procedure3D-printed hybrid resin (P crownV4)

    Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.

06

What researchers measure

Primary outcomes

  1. Modified Plaque Index

    The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque 1. Plaque only detected with the probe 2. Plaque visible with naked eye 3. Abundant plaque

    Time frame: Two months after healing abutment placement

Secondary outcomes

  1. Modified gingival index

    The modified gingival index was used to assess the gingival condition. Each surface was evaluated and assigned a score from 0 to 4: 0 No bleeding 1. Isolated bleeding 2. Confluent bleeding 3. Profuse bleeding

    Time frame: Two months after healing abutment placement

  2. Papilla index (Jemt Index)

    The papilla index (Jemt Index) was used to assess the Papilla condition. 0 No papilla present; no soft tissue curvature; empty space present. 1. Less than half of the papilla height is present 2. At least half of the papilla height is present, but it does not completely fill the space. 3. The papilla fills the entire embrasure space and fills the gap completely (optimal). 4. The papilla is hyperplastic covering too much of the tooth/implant.

    Time frame: Two months after healing abutment placement

07

Study locations

1 site
  • Tanta University - Faculty of Dentistry
    Tanta, El-Gharbia 31773, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07697066
Lead sponsor
Tanta University
Responsible party
Angham Ibrahim Elgendy (Lecturer of Fixed Prosthodontics, Faculty of Dentistry, Tanta University, Egypt, Tanta University) — Principal investigator
First posted
Jul 10, 2026
Start date
Dec 1, 2025
Primary completion
Jul 4, 2026
Completion
Jul 4, 2026
Last update
Jul 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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