Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a presurgical intraoral scan (T0) to create a digital model for volumetric soft tissue analysis.
1 visit (in-person)
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
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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