Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06673576

Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone

Led by British University In Egypt · Updated on 2024-11-05

12

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

B

British University In Egypt

Lead Sponsor

C

Cairo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the precision of the complete crown technique for superimposing 3D digital models to measure changes in gingival tissue volume. This technique was introduced in an earlier in-vitro study as a way to accurately and simply quantify gingival recession. The study focuses on patients scheduled for esthetic crown lengthening, comparing this new method to the gold standard technique for digital volumetric assessment in the esthetic zone. The study involves taking a digital intraoral scan before surgery (T0) and another scan 6 months later (T6). Both scans will be processed using specialized software where the models will be trimmed, repaired if needed, and aligned using either the complete crown technique or the gold standard method. The complete crown technique selects the crown of the tooth near the gingival margin, while the gold standard uses surrounding teeth and palatal gingiva. Accuracy of superimposition will be assessed with heat maps and further analyzed with 3D measurement software. Participants will undergo baseline and 6-month follow-up scans to monitor gingival volume changes and superimposition accuracy. Researchers will carefully check model quality and use software tools to measure alignment precision and tissue changes. The primary outcome is superimposition accuracy at 6 months, with secondary outcomes including marginal and volumetric tissue changes. The total study duration for each participant is 6 months, with follow-up visits for digital assessment and monitoring.

CONDITIONS

Brief Title

Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring esthetic crown lengthening
  • Full-mouth plaque and bleeding score not exceeding 20%
  • Presence of at least 2.5 mm keratinized tissue width
  • Patients motivated to comply with post-operative care instructions and follow-up appointments
Not Eligible

You will not qualify if you...

  • Systemic health conditions that contraindicate or affect healing of periodontal surgery
  • Patients requiring prosthetic crowns or restorations in the esthetic zone
  • Gummy smile with normal tooth proportions
  • Patients treated with medications known to affect the gingiva such as Phenytoin, Cyclosporine, and Nifedipine
  • Smokers
  • Pregnant and nursing females

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a presurgical intraoral scan (T0) to create a digital model for volumetric soft tissue analysis.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are followed for 6 months after the initial scan to monitor soft tissue changes and undergo a second intraoral scan (T6) for comparison.

1 follow-up visit at 6 months (in-person)

Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt, 11230

Actively Recruiting

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Research Team

A

Ahmed Mohamed Hassan, Master Degree of Periodontolog

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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