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

Not Applicable

• Conditions: Patient Satisfaction; Dental Implant
• Interventions: Other: superimposition of DICOM file from CBCT and STL file of Intraoral scanner

• Registration Number: NCT05053958
• Lead Sponsor: Faculty of Dental Medicine for Girls

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.

Study Timeline

• Study Start: 2021-09-07
• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-23
• Primary Completion: 2022-10-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-24
• Last Update Posted: 2023-01-26
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implant planning using superimposition of intraoral scan and CBCT.	superimposition of DICOM file from CBCT and STL file of Intraoral scanner	Patients will receive a pre-operative CBCT examination and optical scan of the oral tissues by intra-oral scanner. Digital Imaging and Communications in Medicine (DICOM) file from the CBCT examination and the Standard Tessellation Language (STL) file from the optical scan will be imported and merged in implant planning software. The virtual implant planning will be performed. The surgical guide and prosthesis are designed according to the virtual plan.

Primary Outcome Measures

Name	Time	Method
White Esthetic Score	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	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	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)	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	3months	using a subjective outcome questionnaire filled out by patient him/herself

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt