Implant ComplicationNCT07760064
This Study Will be Directed Toward Evaluating Peri-implant Tissue Behavior, Pink Esthetic Score, Patient Satisfaction and Marginal Accuracy Associated With Biologically Oriented Preparation Technique for Implant Supported Crowns.
A study testing customized biologically oriented prepared implant abutment in people with Implant Complication, run by Kholoud Mohamed Mahmoud Soliman at 1 site in Egypt.
Trial summary
patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Implant Complication
- What is being tested?
- customized biologically oriented prepared implant abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2023to 20 Feb 2026
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range of patients 20-45 years old, with no gender prediction, able to read and sign the informed consent.
- 2. Patient with missing tooth in the esthetic region indicated for replacement with implant.
- 3. Adjacent and opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically.
- 6. Patient should be willing to return for follow-up examination and evaluation.
Who cannot join
- Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure.
- 7. Recent extraction or extraction socket with infection or remaining root.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Peri-implant Tissue Behavior, Pink Esthetic Score, Patient Satisfaction and Marginal Accuracy Associated With Biologically Oriented Preparation Technique for Implant Supported Crowns
patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol
Construction of the crowns:
Patients in both groups will receive porcelain fused to metal crowns.
Assessment of:
Soft tissue thickness Hard tissue thickness Marginal discrepancy Pink esthetic score Patient satifaction
Read the detailed description
Armamentarium:
To conduct the present study, the following will be used:
- Conventional titanium abutments
- Biologically oriented prepared titanium abutments
- Dental implants
- Intra oral scanner software
Methodology:
- Sample size calculation: a T test was used, according to Mandello etal, study. (31) A sample size (n=20, divided to 10 in each group) will be sufficient to detect a large effect size (d) = 1.4, with an actual power (1-β error) of 0.8 (80%) and a significance level (α error) 0.05 (5%) for two-sided hypothesis test.
- Subject and selection method: The study will be conducted on 20 patients with missing single tooth indicated for implants, attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University. The study will be conducted after obtaining the approval of the Research Ethics Committee (REC), Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt, under code: The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials 7 and techniques. A written informed consent form will be signed from patients prior to study initiation, appendix (1).
- Procedure methodology: Diagnostic procedure: Intra oral examination, cone beam computed tomogram (CBCT) will be taken prior to any procedure. All patients (N=20) will be treated with implants.
- Sample grouping: The patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder titanium abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol with 1 or 1.5 mm below the gingival margin in order to simulate the natural emergence profile of the teeth. Construction of the crowns: Patients in both groups will receive porcelain fused to metal crowns.
- Assessment of:
- Soft tissue thickness: By using intraoral scanner software; Initial measurements that will be taken at the day of definitive crown insertion are compared with those taken at 3, 6 and one year follow-up appointments. (31) 9
- Hard tissue thickness: Marginal bone level will be evaluated directly after insertion of implant, directly before loading, 1, 3, and 6 months after loading, peri-implant bone levels tended to stabilize after this time, and no further marginal bone resorption will occur (33). It will be evaluated by means of standardized parallelized periapical radiographs using an X-ray positioner. (13)
- Marginal discrepancy: It will be evaluated by using the dual scan replica technique.(29) This technique involves making a digital scan of the prepared tooth using the 3D scan settings of the designated software. After the crown fabrication on the prepared tooth model, a light body impression material is used to prepare the impression, which will be then poured on the crown's internal surface after applying a thin layer of separating medium (petroleum jelly). The crown is then seated with an application of finger pressure; after setting of the light body impression material, the crown is detached gently, leaving the light body material coating the prepared tooth surface. Next, this tooth model is scanned again (secondary scan) with the appropriate settings of the designated software. The resultant image is superimposed over the original scan of the prepared tooth. Using the cross-sectional digital tool on the superimposed image, both the original contour of the 10 prepared tooth and the layer of light body material (representing the discrepancy of the internal fit and marginal discrepancy) are visualized and measured utilizing the measurement tool in the software.
- Pink esthetic score: (34) By using standardized intraoral photographs evaluation of Pink Esthetic Score [PES] will be done by two examiners using certain evaluation criteria.
- Patient satisfaction: (35) By using a subjective outcome questionnaire filled out by patient him/herself.
- Statistical analysis Statistical analysis will be performed using a commercially available software program (SPSS Chicago, IL, USA).
Quantitative data will be expressed as mean and standard deviation or median and range according to normality. Independent t test or Mann Whitney U test will be used for comparison.
Categorical data will be described as count and percentages. Data will be compared using chi square test. The level of significance will be set at P≤0.05. All tests will be two tailed.
- Conditions
- Implant Complication
- Being tested
- customized biologically oriented prepared implant abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized biologically oriented prepared implant abutmentProcedure or surgery
custom made zirconia implant abutment
| Study group | Role | What they receive |
|---|---|---|
| conventional shoulder abutment | Active comparator | customized zirconia shoulder implant abutment with screw retained zirconia crown will be fabricated Receives: Procedure: customized biologically oriented prepared implant abutment |
| customized biologically oriented prepared implant abutments | Active comparator | customized zirconia shoulderless implant abutment with screw retained zirconia crown will be fabricated Receives: Procedure: customized biologically oriented prepared implant abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft and hard tissue thickness
by cone beam ct
Measured: 3,6 and 9 moths
marginal discrepancy
by dual scan replica technique
Measured: at delivery time
pink esthetic score and patient satisfaction pink esthetic score and patient satisfaction
by questionnaire
Measured: at delivery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start4 Mar 2023
- Primary completion30 Sep 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kholoud Mohamed Mahmoud Soliman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kholoud Mohamed Mahmoud Soliman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760064
- Sponsor's protocol ID
- P-CR-22-06
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Peri-implant Tissue Behavior, Pink Esthetic Score, Patient Satisfaction and Marginal Accuracy Associated With Biologically Oriented Preparation Technique for Implant Supported Crowns
- ClinicalTrials.gov ID
- NCT07760064
- Acronym / sponsor ID
- P-CR-22-06
- Conditions
- Implant Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kholoud Mohamed Mahmoud SolimanUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 12 Aug 2026 (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.
patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol
Construction of the crowns:
Patients in both groups will receive porcelain fused to metal crowns.
Assessment of:
Soft tissue thickness Hard tissue thickness Marginal discrepancy Pink esthetic score Patient satifaction
Detailed description
Armamentarium:
To conduct the present study, the following will be used:
- Conventional titanium abutments
- Biologically oriented prepared titanium abutments
- Dental implants
- Intra oral scanner software
Methodology:
- Sample size calculation: a T test was used, according to Mandello etal, study. (31) A sample size (n=20, divided to 10 in each group) will be sufficient to detect a large effect size (d) = 1.4, with an actual power (1-β error) of 0.8 (80%) and a significance level (α error) 0.05 (5%) for two-sided hypothesis test.
- Subject and selection method: The study will be conducted on 20 patients with missing single tooth indicated for implants, attending the outpatient clinic of the Crowns and Bridges department, Faculty of Dental Medicine for Girls, Al-Azhar University. The study will be conducted after obtaining the approval of the Research Ethics Committee (REC), Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt, under code: The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials 7 and techniques. A written informed consent form will be signed from patients prior to study initiation, appendix (1).
- Procedure methodology: Diagnostic procedure: Intra oral examination, cone beam computed tomogram (CBCT) will be taken prior to any procedure. All patients (N=20) will be treated with implants.
- Sample grouping: The patients will be divided into two groups (n=10) according to the type of abutment used: Group (1): will receive conventional shoulder titanium abutment. Group (2): will receive customized titanium biologically oriented prepared abutments or shoulderless abutments that are prepared in the same manner as the natural abutment teeth in the BOPT protocol with 1 or 1.5 mm below the gingival margin in order to simulate the natural emergence profile of the teeth. Construction of the crowns: Patients in both groups will receive porcelain fused to metal crowns.
- Assessment of:
- Soft tissue thickness: By using intraoral scanner software; Initial measurements that will be taken at the day of definitive crown insertion are compared with those taken at 3, 6 and one year follow-up appointments. (31) 9
- Hard tissue thickness: Marginal bone level will be evaluated directly after insertion of implant, directly before loading, 1, 3, and 6 months after loading, peri-implant bone levels tended to stabilize after this time, and no further marginal bone resorption will occur (33). It will be evaluated by means of standardized parallelized periapical radiographs using an X-ray positioner. (13)
- Marginal discrepancy: It will be evaluated by using the dual scan replica technique.(29) This technique involves making a digital scan of the prepared tooth using the 3D scan settings of the designated software. After the crown fabrication on the prepared tooth model, a light body impression material is used to prepare the impression, which will be then poured on the crown's internal surface after applying a thin layer of separating medium (petroleum jelly). The crown is then seated with an application of finger pressure; after setting of the light body impression material, the crown is detached gently, leaving the light body material coating the prepared tooth surface. Next, this tooth model is scanned again (secondary scan) with the appropriate settings of the designated software. The resultant image is superimposed over the original scan of the prepared tooth. Using the cross-sectional digital tool on the superimposed image, both the original contour of the 10 prepared tooth and the layer of light body material (representing the discrepancy of the internal fit and marginal discrepancy) are visualized and measured utilizing the measurement tool in the software.
- Pink esthetic score: (34) By using standardized intraoral photographs evaluation of Pink Esthetic Score [PES] will be done by two examiners using certain evaluation criteria.
- Patient satisfaction: (35) By using a subjective outcome questionnaire filled out by patient him/herself.
- Statistical analysis Statistical analysis will be performed using a commercially available software program (SPSS Chicago, IL, USA).
Quantitative data will be expressed as mean and standard deviation or median and range according to normality. Independent t test or Mann Whitney U test will be used for comparison.
Categorical data will be described as count and percentages. Data will be compared using chi square test. The level of significance will be set at P≤0.05. All tests will be two tailed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional shoulder abutment | Active comparator | Procedure: customized biologically oriented prepared implant abutmentcustomized zirconia shoulder implant abutment with screw retained zirconia crown will be fabricated |
| customized biologically oriented prepared implant abutments | Active comparator | Procedure: customized biologically oriented prepared implant abutmentcustomized zirconia shoulderless implant abutment with screw retained zirconia crown will be fabricated |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age range of patients 20-45 years old, with no gender prediction, able to read and sign the informed consent.
- 2. Patient with missing tooth in the esthetic region indicated for replacement with implant.
- 3. Adjacent and opposing natural teeth should be present. 4. The edentulous ridge should be free from any infection or remining root. 5. Patient should be able to tolerate surgical procedure of implant procedures physically and psychologically.
- 6. Patient should be willing to return for follow-up examination and evaluation.
Key exclusion criteria (2 listed)
- Patients with active periodontal diseases. 2. Patient with poor oral hygiene and motivation. 3. Pregnant women. 4. Patient with unrealistic expectations. 5. Patients with parafunctional habits and smoker. 6. Patient with systemic disease and immunocompromised patients which will prevent surgical procedure.
- 7. Recent extraction or extraction socket with infection or remaining root.
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 |
|---|---|---|
| customized biologically oriented prepared implant abutmentcustom made zirconia implant abutment | Procedure or surgery | conventional shoulder abutment, customized biologically oriented prepared implant abutments |
Primary outcome
soft and hard tissue thickness
Time frame: 3,6 and 9 moths
by cone beam ct
marginal discrepancy
Time frame: at delivery time
by dual scan replica technique
pink esthetic score and patient satisfaction pink esthetic score and patient satisfaction
Time frame: at delivery time
by questionnaire
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 12 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing customized biologically oriented prepared implant abutment in people with Implant Complication, run by Kholoud Mohamed Mahmoud Soliman 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 4 inclusion and 2 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 12 Aug 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?
soft and hard tissue thickness (time frame: 3,6 and 9 moths). The study lists 3 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 12 Aug 2026.