Clinical trial NCT05053958: Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.
Official title: Patients' Satisfaction and Aesthetic Outcomes of Single Implant Restorations in Aesthetic Zone Using Superimposition of Intra-Oral Scan and CBCT.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Patient Satisfaction
Keywords: digital Implantology
patient reported outcomes
guided surgery
aesthetic outcomes
accuracy
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2021-09-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pink Esthetic Score
timeFrame: 0-3 month
measure: Implant Crown Aesthetic Index
timeFrame: 0-3months
measure: White Esthetic Score
timeFrame: 0-3 months
measure: Peri-Implant and Crown Index (PICI)
timeFrame: 0-3months
measure: Patient satisfaction level
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: Professor & Head of Crowns and Bridges Department Faculty of Dental Medicine for Girls
name: Osama S Abdel Ghani
role: STUDY_DIRECTOR
affiliation: Lecturer of Crowns and Bridges Faculty of Dental Medicine for Girls
name: Roqaia M Alassar
role: STUDY_DIRECTOR
References: