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Clinical Trials/NCT07760064
NCT07760064CompletedNot Applicable

Assessment of Peri-implant Tissue Behavior, Pink Esthetic Score, Patient Satisfaction and Marginal Accuracy Associated With Biologically Oriented Preparation Technique for Implant Supported Crowns

Kholoud Mohamed Mahmoud Soliman1 site in 1 country20 target enrollmentStarted: March 4, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
marginal discrepancy

Study Overview

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

Detailed Description

Armamentarium:

To conduct the present study, the following will be used:

  1. Conventional titanium abutments
  2. Biologically oriented prepared titanium abutments
  3. Dental implants
  4. Intra oral scanner software

Methodology:

  1. Sample size calculation:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

conventional shoulder abutment

Active Comparator

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

Intervention: customized biologically oriented prepared implant abutment (Procedure)

customized biologically oriented prepared implant abutments

Active Comparator

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

Intervention: customized biologically oriented prepared implant abutment (Procedure)

Outcomes

Primary Outcomes

marginal discrepancy

Time Frame: at delivery time

by dual scan replica technique

soft and hard tissue thickness

Time Frame: 3,6 and 9 moths

by cone beam ct

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

Time Frame: at delivery time

by questionnaire

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kholoud Mohamed Mahmoud Soliman
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Kholoud Mohamed Mahmoud Soliman

Specialist prosthodontist

Al-Azhar University

Study Sites (1)

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