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Relationship Between Soft Tissue Volume and Gingival Phenotype: a Novel Classification System

Relationship Between Soft Tissue Volume and Gingival Phenotype: a Novel Classification System

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06348823
Enrollment
56
Registered
2024-04-05
Start date
2024-02-25
Completion date
2025-10-31
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Biotype, Soft Tissue

Keywords

soft tissue volume

Brief summary

Different classifications to describe alveolar ridge defects have been published over the past years but no single classification has been developed concerning soft tissue volume around teeth or dental implants. Moreover, while several studies investigated the effect of various augmentation techniques and materials on soft tissue volume change and volume stability there is a real gap of knowledge regarding how to evaluate the available soft tissue volume and when to consider it sufficient or deficient which would definitely improve clinical decision making and treatment planing. Therefore, our primary aim was to assess the application of a novel classification system based on the correlation between buccal soft tissue volume and gingival biotypes and, also to assess the sensitivity of such novel method.

Interventions

DIAGNOSTIC_TESTvolume survey

All subjects received oral hygiene instructions and, if needed, a dental cleaning of plaque and calculus. After calibration using digital photographs, intraoral scans, and CBCT, one dentist, who was not involved in the screening phase to avoid any bias, obtained all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width). Two test subjects were examined prior starting with enrollment and data collection.

Sponsors

British University In Egypt
CollaboratorOTHER
Ain Shams University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adult patients in a healthy systemic condition who required comprehensive dental treatment. 2. Both genders with age group \> 18 years old. 3. CBCT scans will be obtained as a part of the comprehensive dental treatment. 4. Patients should approve to deliver a signature to a written consent after study nature explanation.

Exclusion criteria

1. Patients with severe smoking habits \>10 cig \\ day. 2. Pregnant females, decisional impaired individuals, Prisoners and handicapped patients. 3. Patients having poor oral hygiene or not wanting to carry out oral hygiene measures. 4. Patients with fillings or crowns in the central incisors. 5. Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin),

Design outcomes

Primary

MeasureTime frameDescription
soft tissue volume - biotype correlation3 monthsThe association between gingival biotype and buccal soft tissue volume will be analyzed. Sensitivity and specificity of this novel method will be assessed.

Countries

Egypt

Contacts

Primary ContactAhmed Hamdy
ahmed.esmaail@bue.edu.eg+201061112512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026