Clinical trial NCT04214041: Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation
Official title: Soft Tissue Volume Augmentation of Localized Horizontal Ridge Defects Using Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This non-inferiority study was designed as a randomized controlled clinical trial including 26 localized horizontal ridge defects that were equally allocated (1:1) into one of two parallel groups.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.

Detailed description: A total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria University. Ridge defects were divided into two parallel groups:

Test group: localized ridge defects were augmented using autologous fat grafting Control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.

Eligibility criteria: Inclusion Criteria:

1. Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation.
2. Teeth in the defect area have been extracted at least 3 months prior to enrolment
3. All patients were systemically healthy
4. Patients were non-smokers
5. Patients had abdominal fat accumulation allowing liposuction
6. Ability to understand the nature of the proposed surgery and ability to sign an informed consent form

Exclusion Criteria:

1. General contra-indications to surgical procedures
2. Pregnancy
3. Systemic diseases like Diabetes Mellitus and autoimmune diseases
4. History of malignancy, chemotherapy or radiotherapy within the last 5 years
5. Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Primary outcomes:
measure: Volumetric analysis to evaluate soft tissue volume changes
timeFrame: 1 month
measure: Volumetric analysis to evaluate soft tissue volume changes
timeFrame: 2 months
measure: Volumetric analysis to evaluate soft tissue volume changes
timeFrame: 3 months
Secondary outcomes:
measure: Probing depth
timeFrame: 1 month
measure: Probing depth
timeFrame: 2 months
measure: Probing depth
timeFrame: 3 months
measure: Clinical attachment loss (CAL)
timeFrame: 1 month
measure: Clinical attachment loss (CAL)
timeFrame: 2 months
measure: Clinical attachment loss (CAL)
timeFrame: 3 months
measure: Bleeding on probing
timeFrame: 1 month
measure: Bleeding on probing
timeFrame: 2 months
measure: Bleeding on probing
timeFrame: 3 months
measure: Width of Keratinized tissue
timeFrame: 1 month
measure: Width of Keratinized tissue
timeFrame: 2 months
measure: Width of Keratinized tissue
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Yasmine Gaweesh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Maha A Abou Khadr, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Hussein S Abulhassan, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nesma M Khalil, PhD
role: STUDY_CHAIR
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