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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05053958
• Other study ID #: P-CR-21-06
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: April 2023

Study information

• Verified date: January 2023
• Source: Faculty of Dental Medicine for Girls
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14
• Est. completion date: April 2023
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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).

3. Good treatment compliance.

Exclusion Criteria:

1. Presence of uncontrolled systemic diseases, infection, or inflammation around the implant sites.

2. Pregnancy or lactation.

3. Poor oral hygiene habits.

4. Psychiatric problems, alcohol, tobacco (>10 cigarettes per day) or drug abuse.

5. Severe bruxism or clenching.

6. Not able to complete the follow-up.

Related Conditions & MeSH terms

• Dental Implant
• Patient Satisfaction

Intervention

Other:
• superimposition of DICOM file from CBCT and STL file of Intraoral scanner
These files will be imported in implant planning software,and virtual implant planning will be performed.

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Dental Medicine for Girls

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pink Esthetic Score	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.	0-3 month
Primary	Implant Crown Aesthetic Index	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.	0-3months
Primary	White Esthetic Score	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.	0-3 months
Primary	Peri-Implant and Crown Index (PICI)	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.	0-3months
Primary	Patient satisfaction level	using a subjective outcome questionnaire filled out by patient him/herself	3months