NCT07760064

Brief Summary

patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol Construction of the crowns: Patients in both groups will receive porcelain fused to metal crowns. Assessment of: Soft tissue thickness Hard tissue thickness Marginal discrepancy Pink esthetic score Patient satifaction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration 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

March 4, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2.6 years

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • soft and hard tissue thickness

    by cone beam ct

    3,6 and 9 moths

  • marginal discrepancy

    by dual scan replica technique

    at delivery time

  • pink esthetic score and patient satisfaction pink esthetic score and patient satisfaction

    by questionnaire

    at delivery time

Study Arms (2)

conventional shoulder abutment

ACTIVE COMPARATOR

customized zirconia shoulder implant abutment with screw retained zirconia crown will be fabricated

Procedure: customized biologically oriented prepared implant abutment

customized biologically oriented prepared implant abutments

ACTIVE COMPARATOR

customized zirconia shoulderless implant abutment with screw retained zirconia crown will be fabricated

Procedure: customized biologically oriented prepared implant abutment

Interventions

custom made zirconia implant abutment

conventional shoulder abutmentcustomized biologically oriented prepared implant abutments

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range of patients 20-45 years old, with no gender prediction, able to read and sign the informed consent.
  • \. Patient with missing tooth in the esthetic region indicated for replacement with implant.
  • \. Adjacent and opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically.
  • \. Patient should be willing to return for follow-up examination and evaluation.

You may not qualify if:

  • \- Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure.
  • \. Recent extraction or extraction socket with infection or remaining root.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar University

Cairo, Nasr City, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist prosthodontist

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start

March 4, 2023

Primary Completion

September 30, 2025

Study Completion

February 20, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations