Clinical trial NCT06348823: Relationship Between Soft Tissue Volume and Gingival Phenotype: a Novel Classification System
Official title: Relationship Between Soft Tissue Volume and Gingival Phenotype: a Novel Classification System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gingival Biotype
Soft Tissue
Keywords: soft tissue volume
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: British University In Egypt
First posted: 2024-04-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This cross sectional observational clinical study will include ---- patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt.

Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent.

The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guideline of the research ethical committee in line with the Helsinki Declaration of 1975.

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.


Eligibility criteria: 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),

Primary outcomes:
measure: soft tissue volume - biotype correlation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Hamdy
Study officials:
affiliation: British University In Egypt
name: AHMED HAMDY MAHMOUD MAHMOUD
role: PRINCIPAL_INVESTIGATOR
References: