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Completed

NCT Number: NCT07697066

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

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

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Key information

Conditions

Implant 3D Printed Hybrid Resin Healing Polyether Ether Ether Ketone

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University - Faculty of Dentistry

Tanta, El-Gharbia, 31773, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Titanium healing abutment

Procedure

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

Polyetheretherketone (PEEK)

Procedure

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

3D-printed hybrid resin (P crownV4)

Procedure

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

Primary outcomes

  1. Modified Plaque Index

    Time frame: Two months after healing abutment placement

    The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque

    • Plaque only detected with the probe
    • Plaque visible with naked eye
    • Abundant plaque

Secondary outcomes

  1. Modified gingival index

    Time frame: Two months after healing abutment placement

    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

    • Isolated bleeding
    • Confluent bleeding
    • Profuse bleeding

  2. Papilla index (Jemt Index)

    Time frame: Two months after healing abutment placement

    The papilla index (Jemt Index) was used to assess the Papilla condition. 0 No papilla present; no soft tissue curvature; empty space present.

    • Less than half of the papilla height is present
    • At least half of the papilla height is present, but it does not completely fill the space.
    • The papilla fills the entire embrasure space and fills the gap completely (optimal).
    • The papilla is hyperplastic covering too much of the tooth/implant.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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