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

NCT05053958 | Unknown

• 1 other identifier: P-CR-21-06
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Patient Satisfaction

Keywords

digital Implantology; patient reported outcomes; guided surgery; aesthetic outcomes; accuracy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• Patient satisfaction level

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

  3months

Study Arms (2)

Implant planning without using superimposition of intraoral scan and CBCT.

NO INTERVENTION

Patients will receive a pre-operative CBCT examination. Implants will be inserted using freehand drilling protocol. The implants will be placed using flapless technique with the reference of neighboring teeth and 3D radiographic information.

Implant planning using superimposition of intraoral scan and CBCT.

ACTIVE COMPARATOR

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.

Other: superimposition of DICOM file from CBCT and STL file of Intraoral scanner

Interventions

superimposition of DICOM file from CBCT and STL file of Intraoral scanner OTHER

These files will be imported in implant planning software,and virtual implant planning will be performed.

Implant planning using superimposition of intraoral scan and CBCT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Osama S Abdel Ghani

  Professor & Head of Crowns and Bridges Department Faculty of Dental Medicine for Girls

  STUDY DIRECTOR

• Roqaia M Alassar

  Lecturer of Crowns and Bridges Faculty of Dental Medicine for Girls

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of fixed prosthodontics department

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 23, 2021
• Study Start: September 7, 2021
• Primary Completion: October 7, 2022
• Study Completion: April 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

EG (1)