Ireland
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Recruiting Not applicable

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

NCT06673576 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2024-03-15
Last updated
2024-11-05

Condition(s) studied

Volume AssessmentGummy Smile

Investigational drug(s) / intervention(s)

Complete crown technique for superimpositionGold standard technique for superimposition

Complete crown technique for superimposition: the complete crown technique, the crown of the tooth corresponding to the gingival margin under evaluation will be selected using the paint method and circular selection tool. The same selection process will be applied to the moving model.

Gold standard technique for superimposition: the gold standard technique, adjacent intact teeth and a portion of the palatal gingiva will be selected. Superimpositions will be executed utilizing the software's iterative closest point algorithm (ICP).

Study summary

The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. (2023) as a means to achieve an accurate, reproducible, and simple method for quantification of gingival recession.

This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening, with predefined inclusion and exclusion

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patients requiring esthetic crown lengthening. 2. Full-mouth plaque and bleeding score not exceeding 20%. 3. Presence of at least 2.5 mm keratinized tissue width (Pontoriero \& Carnevale, 2001). 4. Patients showing motivation to comply with post-operative care instructions and follow-up appointments. Exclusion Criteria: * 1\. Systemic health conditions that contraindicate or affect healing of periodontal surgery. 2\. Patients requiring prosthetic crowns or restorations in the esthetic zone. 3. Gummy smile with normal tooth proportions. 4. Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine). 5\. Smokers. 6. Pregnant and nursing females.

Primary outcome measure(s)

  • Superimposition accuracy — 6 months
    Models will be exported in superimposed orientations to the Geomagic software for the measurement of superimposition accuracy, specifically the root mean square of the tooth corresponding to the gingival margin where volumetric changes are of interest, using the 3D compare tool in Geomagic software.

Trial sites (1)

FacilityCityRegionStatus
Cairo University Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06673576 on ClinicalTrials.gov ↗ ← All trials in Egypt