NCT07697066

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

ImplantHealingPolyether Ether Ether Ketone3D Printed Hybrid Resin

Outcome Measures

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

    Two months after healing abutment placement

Secondary Outcomes (2)

  • Modified gingival index

    Two months after healing abutment placement

  • Papilla index (Jemt Index)

    Two months after healing abutment placement

Study Arms (3)

Group I

ACTIVE COMPARATOR

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

Procedure: Titanium healing abutment

Group II

EXPERIMENTAL

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

Procedure: Polyetheretherketone (PEEK)

Group III

EXPERIMENTAL

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

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

Interventions

Titanium healing abutmentPROCEDURE

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

Group I
Polyetheretherketone (PEEK)PROCEDURE

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

Group II
3D-printed hybrid resin (P crownV4)PROCEDURE

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

Group III

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University - Faculty of Dentistry

Tanta, El-Gharbia, 31773, Egypt

Location

MeSH Terms

Interventions

polyetheretherketone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Fixed Prosthodontics, Faculty of Dentistry, Tanta University, Egypt

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start

December 1, 2025

Primary Completion

July 4, 2026

Study Completion

July 4, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations

EG(1)