Patient SatisfactionNCT06702969
Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile
A study testing Intra oral scanner and impression analog in people with Patient Satisfaction, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing: 1. pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives 2. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Intra oral scanner and impression analog
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 16 May 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders within age range of 20-50 years.
- Systemically healthy participants classified as American Society of Anesthesiologists( ASA ) class I . Guided by medical questionnaire modified from Burkett's
- Single non restorable tooth in upper anterior esthetic zone with at least 4 mm bone present apical to the root apex for primary stability.
- Type I extraction sockets according to classification.
- Ability to attend the surgery , comply to it's procedures , the recall visits and oral hygiene protocol .
- Thick gingival phenotype with thickness ≥ 2 mm around the non-restorable tooth -
Who cannot join
- Missing adjacent teeth or opposing tooth. .
- Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.
- Smokers.
- Pregnant or lactating females.
- Patients with para-functional habits (bruxism and/or clenching)
- Vulnerable groups (handicapped, orphans, and prisoners). -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: A Randomized Controlled Trial
This randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing:
- pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives
- Patients' satisfaction and clinical outcomes as secondary objectives
Read the detailed description
fourteen patients with single nonrestorable tooth in the esthetic zone participated in the study and were replaced with immediate implants with immediate customized provisional restoration after 3 months they recalled for the impression, seven with digital and the others with conventional and evaluated.
- Conditions
- Patient Satisfaction
- Being tested
- Intra oral scanner, impression analog
- Keywords
- Immediate implant, Digital impression, Pink esthetic score, Conventional impression
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra oral scannerDevice
Also called implant placement
Immediate implant placement with customized healing abutment and after three months placement all ceramic crown by digital impression using intra oral scanner
impression analogDevice
Also called implant placement, impression copying
Immediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression
| Study group | Role | What they receive |
|---|---|---|
| Digital impression with intraoral scanner | Active comparator | included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with full digital procedure consisting of digital impression with intraoral scanner, and Computer Aided Design/ Computer Aided Manufacture (CAD/CAM) procedure. Receives: Device: Intra oral scanner |
| conventional impression technique | Active comparator | included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with Conventional impression-taking with polyvinyl siloxane, plaster model pouring and lost-wax casting technique Receives: Device: impression analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
pink esthetic score
The pink esthetic score is based on seven variables:
- Mesial papilla
- Distal papilla
- Soft-tissue level
- Soft- tissue contour
- Alveolar process deficiency
- Soft-tissue color and texture Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score
Measured: at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement
marginal bone loss
described by millimeter using paralleling technique
Measured: immediately after crown placement (baseline), then three months after crown placement
Secondary outcomes (3)
patient satisfaction
satisfaction questionnaire modified from based on 10 specific questions.
The questions were as follows:
- Are you satisfied with the treatment? with 0 = very dissatisfied and 100 = very satisfied
- Did you experience discomfort during the impression-taking? with 0 = high discomfort and 100 = no discomfort
- Did you experience gag reflex/nausea during the impression-taking? with 0 = strong gag reflex/nausea, and 100 = no gag reflex/nausea
- How comfortable was the impression procedure? with 0 = uncomfortable and 100 = comfortable
- Does your implant-supported restoration function well? with 0 = bad function and 100 = well function
Measured: after crown placement
plaque index
0 = No plaque in gingival area.
- = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface.
- = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
- of sites positive for dental plaque will be calculated for each case.
Measured: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
gingival index
0 = Normal gingiva.
- = Mild inflammation, slight change in color, slight edema; no bleeding on probing.
- = Moderate inflammation, redness, edema, and glazing; bleeding on probing.
- = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.
Measured: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start15 Jun 2022
- Primary completion25 Mar 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ola A ezzat, professsor, Study director, faculty of dentistry-Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702969
- Sponsor's protocol ID
- Digitalized Impression
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06702969
- Acronym / sponsor ID
- Digitalized Impression
- Conditions
- Patient Satisfaction
- Keywords
- Immediate implant, Digital impression, Pink esthetic score, Conventional impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 25 Nov 2024 (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 randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing:
- pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives
- Patients' satisfaction and clinical outcomes as secondary objectives
Detailed description
fourteen patients with single nonrestorable tooth in the esthetic zone participated in the study and were replaced with immediate implants with immediate customized provisional restoration after 3 months they recalled for the impression, seven with digital and the others with conventional and evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital impression with intraoral scanner | Active comparator | Device: Intra oral scannerincluded seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with full digital procedure consisting of digital impression with intraoral scanner, and Computer Aided Design/ Computer Aided Manufacture (CAD/CAM) procedure. |
| conventional impression technique | Active comparator | Device: impression analogincluded seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with Conventional impression-taking with polyvinyl siloxane, plaster model pouring and lost-wax casting technique |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders within age range of 20-50 years.
- Systemically healthy participants classified as American Society of Anesthesiologists( ASA ) class I . Guided by medical questionnaire modified from Burkett's
- Single non restorable tooth in upper anterior esthetic zone with at least 4 mm bone present apical to the root apex for primary stability.
- Type I extraction sockets according to classification.
- Ability to attend the surgery , comply to it's procedures , the recall visits and oral hygiene protocol .
Key exclusion criteria (6 listed)
- Missing adjacent teeth or opposing tooth. .
- Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.
- Smokers.
- Pregnant or lactating females.
- Patients with para-functional habits (bruxism and/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 |
|---|---|---|
| Intra oral scannerAlso: implant placementImmediate implant placement with customized healing abutment and after three months placement all ceramic crown by digital impression using intra oral scanner | Device | Digital impression with intraoral scanner |
| impression analogAlso: implant placement, impression copyingImmediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression | Device | conventional impression technique |
Primary outcome
pink esthetic score
Time frame: at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement
The pink esthetic score is based on seven variables: * Mesial papilla * Distal papilla * Soft-tissue level * Soft- tissue contour * Alveolar process deficiency * Soft-tissue color and texture Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score
marginal bone loss
Time frame: immediately after crown placement (baseline), then three months after crown placement
described by millimeter using paralleling technique
3 secondary outcomes
patient satisfaction
Time frame: after crown placement
plaque index
Time frame: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
gingival index
Time frame: Immediately after crown placement (baseline), one months later , and finally three months after crown placement
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
ola A ezzat, professsor study director
faculty of dentistry-Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra oral scanner and impression analog in people with Patient Satisfaction, run by Ain Shams University 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 6 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 25 Sep 2025. 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: at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement). The study lists 2 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 25 Sep 2025.