Dental ImplantNCT05053958
Using Superimposition of Intra-Oral Scan and CBCT in Single Implant Restorations in Aesthetic Zone.
A study testing superimposition of DICOM file from CBCT and STL file of Intraoral scanner in people with Dental Implant and Patient Satisfaction, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Patient Satisfaction
- What is being tested?
- superimposition of DICOM file from CBCT and STL file of Intraoral scanner
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2021to 5 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients' Satisfaction and Aesthetic Outcomes of Single Implant Restorations in Aesthetic Zone Using Superimposition of Intra-Oral Scan and CBCT.
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.
Read the 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:
- DICOM file of CBCT for examination of single implant in aesthetic zone.
- STL file of optical scanning for examination of single implant in aesthetic zone.
- An implant planning software.
- One type of dental implant.
- Conditions
- Dental Implant, Patient Satisfaction
- Being tested
- superimposition of DICOM file from CBCT and STL file of Intraoral scanner
- Keywords
- digital Implantology, patient reported outcomes, guided surgery, aesthetic outcomes, accuracy
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superimposition of DICOM file from CBCT and STL file of Intraoral scannerOther
These files will be imported in implant planning software,and virtual implant planning will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: superimposition of DICOM file from CBCT and STL file of Intraoral scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-3months
Patient satisfaction level
using a subjective outcome questionnaire filled out by patient him/herself
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start7 Sep 2021
- Primary completion7 Oct 2022
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Mohamed Aboulftouh Ahmed, Faculty of Dental Medicine for Girls
- Investigators
- Osama S Abdel Ghani, Study director, Professor & Head of Crowns and Bridges Department Faculty of Dental Medicine for GirlsRoqaia M Alassar, Study director, Lecturer of Crowns and Bridges Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053958
- Sponsor's protocol ID
- P-CR-21-06
- Status last verified
- Oct 2026
- First submitted
- 8 Sep 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Satisfaction and Aesthetic Outcomes of Single Implant Restorations in Aesthetic Zone Using Superimposition of Intra-Oral Scan and CBCT.
- ClinicalTrials.gov ID
- NCT05053958
- Acronym / sponsor ID
- P-CR-21-06
- Conditions
- Dental Implant, Patient Satisfaction
- Keywords
- digital Implantology, patient reported outcomes, guided surgery, aesthetic outcomes, accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- DICOM file of CBCT for examination of single implant in aesthetic zone.
- STL file of optical scanning for examination of single implant in aesthetic zone.
- An implant planning software.
- One type of dental implant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: superimposition of DICOM file from CBCT and STL file of Intraoral scannerPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superimposition of DICOM file from CBCT and STL file of Intraoral scannerThese files will be imported in implant planning software,and virtual implant planning will be performed. | Other | Implant planning using superimposition of intraoral scan and CBCT. |
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama S Abdel Ghani study director
Professor & Head of Crowns and Bridges Department Faculty of Dental Medicine for Girls
Roqaia M Alassar study director
Lecturer of Crowns and Bridges Faculty of Dental Medicine for Girls
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superimposition of DICOM file from CBCT and STL file of Intraoral scanner in people with Dental Implant and Patient Satisfaction, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pink Esthetic Score (time frame: 0-3 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.