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 | Recruiting DMC

• 1 other identifier: 131024
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Volume Assessment; Gummy Smile

Outcome Measures

Primary Outcomes (1)

• Superimposition accuracy

  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.

  6 months

Secondary Outcomes (1)

• Marginal and Volumetric changes

  6 months

Study Arms (1)

Patients assigned for esthetic crown leghthening

EXPERIMENTAL

Diagnostic Test: Complete crown technique for superimposition; Diagnostic Test: Gold standard technique for superimposition

Interventions

Complete crown technique for superimposition DIAGNOSTIC_TEST

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.

Patients assigned for esthetic crown leghthening

Gold standard technique for superimposition DIAGNOSTIC_TEST

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).

Patients assigned for esthetic crown leghthening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring esthetic crown lengthening.
• Full-mouth plaque and bleeding score not exceeding 20%.
• Presence of at least 2.5 mm keratinized tissue width (Pontoriero \& Carnevale, 2001).
• Patients showing motivation to comply with post-operative care instructions and follow-up appointments.

You may not qualify if:

• \. Systemic health conditions that contraindicate or affect healing of periodontal surgery.
• \. 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).
• \. Smokers. 6. Pregnant and nursing females.

Sponsors & Collaborators

• British University In Egypt: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University

Cairo, 11230, Egypt

RECRUITING

Central Study Contacts

Ahmed Mohamed Hassan, Master Degree of Periodontolog

CONTACT

+201060683334; ahmed.hasan@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: November 5, 2024
• Study Start: March 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: May 15, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)