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
1 other identifier
interventional
12
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
June 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJune 13, 2024
June 1, 2024
3 months
June 9, 2024
June 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Superimposition accuracy
Using Geomagic Software (RMS) in Millimeter(mm)
6 months
Secondary Outcomes (4)
Soft tissue volumetric Changes
6 months
Gingival Margin level change
6 months
Intra-Inter Assessor reliability
6 months
Operator's satisfaction
6 months
Study Arms (1)
group I
EXPERIMENTALcomplete crown technique for superimposition of digital models
Interventions
Eligibility Criteria
You may qualify if:
- Patients aged 18 years or older.
- 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.
- Gummy smile with normal tooth proportions.
- Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
- Smokers.
- Pregnant and nursing females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- British University In Egyptlead
- Cairo Universitycollaborator
Study Sites (1)
Ahmed Hassan
Cairo, 112344, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
June 9, 2024
First Posted
June 13, 2024
Study Start
June 15, 2024
Primary Completion
August 31, 2024
Study Completion
December 30, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06