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Clinical Trials/NCT05053958
NCT05053958
Enrolling By Invitation
Not Applicable

Patients' Satisfaction and Aesthetic Outcomes of Single Implant Restorations in Aesthetic Zone Using Superimposition of Intra-Oral Scan and CBCT.

Faculty of Dental Medicine for Girls1 site in 1 country14 target enrollmentSeptember 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
Faculty of Dental Medicine for Girls
Enrollment
14
Locations
1
Primary Endpoint
White Esthetic Score
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

Brief Summary

This study will be performed to evaluate patients'satisfaction and aesthetic outcomes of single implant restorations in aesthetic zone by using superimposition of intra-oral scan and CBCT.

Detailed Description

The accurate transfer of an ideal implant position from virtual planning to the actual implant site is essential for protecting vital structures as well as optimizing esthetic and functional outcomes.With the introduction of 3D imaging and implant planning software, preoperative design for a "prosthesis-driven" implant position becomes a reality. The initial stage is digital image acquisition, which can be from extra-oral means such as cone beam computed tomography (CBCT) and laboratory scanners, or intraoral means such as intraoral scanners. Image fusion or superimposition of the STL data obtained from the optical scanning, with the DICOM data obtained from the CBCT, is performed by matching the common reference points prior to implant planning. The superimposed images enable virtual implant planning, while taking the surrounding anatomic structures and future prosthetic needs into consideration. To conduct the present study, the following will be used: 1. DICOM file of CBCT for examination of single implant in aesthetic zone. 2. STL file of optical scanning for examination of single implant in aesthetic zone. 3. An implant planning software. 4. One type of dental implant.

Registry
clinicaltrials.gov
Start Date
September 7, 2021
End Date
April 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Faculty of Dental Medicine for Girls
Responsible Party
Principal Investigator
Principal Investigator

Dina Mohamed Aboulftouh Ahmed

assistant lecturer of fixed prosthodontics department

Faculty of Dental Medicine for Girls

Eligibility Criteria

Inclusion Criteria

  • At least 1 tooth having missed within 3-4 months or to be extracted in anterior zone, and the remaining teeth are adequate to support the surgical template.
  • Sufficient bone tissue to insert an implant without any need for augmentation (the residual bone height ≥ 10 mm, the buccolingual width ≥ 7 mm, and the labial bone plate is complete without bone dehiscence and fenestration).
  • Good treatment compliance.

Exclusion Criteria

  • Presence of uncontrolled systemic diseases, infection, or inflammation around the implant sites.
  • Pregnancy or lactation.
  • Poor oral hygiene habits.
  • Psychiatric problems, alcohol, tobacco (\>10 cigarettes per day) or drug abuse.
  • Severe bruxism or clenching.
  • Not able to complete the follow-up.

Outcomes

Primary Outcomes

White Esthetic Score

Time Frame: 0-3 months

A total of five variables (tooth form,tooth volume/outline, color, surface texture and translucency) assessing implant crown esthetics using a score from 0 = worst to 2 = best result. The highest possible score of 0 reflects perfect implant esthetics with that of the contra-lateral tooth.

Implant Crown Aesthetic Index

Time Frame: 0-3months

A total of nine variables ( Width ,Length ,Labial convexity ,Color/translucency,Surface,Labial margin ,Papillae, Contour of the labial surface,Color and surface) assessing implant crown and soft tissue esthetics using the score of 0=no deviation, 1= small deviation and 5=large deviation. The maximum score of 45 points reflects perfect implant esthetics with that of contra lateral and adjacent tooth.

Pink Esthetic Score

Time Frame: 0-3 month

A total of seven variables (mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour,alveolar process deficiency, soft-tissue color,and soft-tissue texture) assessing soft tissue around single implant supported restoration with a score of 0 to 2 (0 representing the poorest and 2 the best result) . The maximum score of 14 points reflects perfect implant esthetics with that of the contra lateral tooth.

Peri-Implant and Crown Index (PICI)

Time Frame: 0-3months

A total of six variables (Papillae ,Zenith ,Root convexity o f the peri implant mucosa and Shape ,Color ,Characterization of the implant crown )assessing crown,mucosa and Overall crown and mucosa compared to contra lateral tooth using 100 mm visual analogue scale.

Patient satisfaction level

Time Frame: 3months

using a subjective outcome questionnaire filled out by patient him/herself

Study Sites (1)

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