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

July 5, 2026 updated by: Angham Ibrahim Elgendy, Tanta University

Influence of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
Patients received a standard ready-made titanium healing abutment (control group).
Procedure: Titanium healing abutment
Patients received a standard ready-made titanium healing abutment (control group).
Experimental: Group II
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
Procedure: Polyetheretherketone (PEEK)
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
Experimental: Group III
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
Procedure: 3D-printed hybrid resin (P crownV4)
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. Plaque only detected with the probe
  2. Plaque visible with naked eye
  3. Abundant plaque
Two months after healing abutment placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

  1. Isolated bleeding
  2. Confluent bleeding
  3. Profuse bleeding
Two months after healing abutment placement
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.

  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.
Two months after healing abutment placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

July 4, 2026

Study Completion (Actual)

July 4, 2026

Study Registration Dates

First Submitted

July 5, 2026

First Submitted That Met QC Criteria

July 5, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-FP-11-25-3233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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