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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • AlAzhar University

    Cairo, Nasr City, 002

Other trials in Egypt

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:

  1. Conventional titanium abutments
  2. Biologically oriented prepared titanium abutments
  3. Dental implants
  4. Intra oral scanner software

Methodology:

  1. 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.
  2. 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).
  3. 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.
  4. 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.
  5. Assessment of:
  6. 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
  7. 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)
  8. 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.
  9. 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.
  10. Patient satisfaction: (35) By using a subjective outcome questionnaire filled out by patient him/herself.
  11. 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.

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 groups in NCT07760064
Study groupRoleWhat they receive
conventional shoulder abutmentActive comparatorcustomized 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 abutmentsActive comparatorcustomized 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.

  1. soft and hard tissue thickness

    by cone beam ct

    Measured: 3,6 and 9 moths

  2. marginal discrepancy

    by dual scan replica technique

    Measured: at delivery time

  3. 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.

  1. First posted12 Aug 2026
  2. Study start4 Mar 2023
  3. Primary completion30 Sep 2025
  4. Study completion20 Feb 2026

Resources

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)
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

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.

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