Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Other: Autologous fat grafting; Other: Sub-epithelial connective tissue graft

• Registration Number: NCT04214041
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2018-12-17
• Primary Completion: 2019-06-25
• Study Completion: 2019-09-11
• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous fat grafting	Autologous fat grafting	-
Sub-epithelial connective tissue graft	Sub-epithelial connective tissue graft	-

Primary Outcome Measures

Name	Time	Method
Volumetric analysis to evaluate soft tissue volume changes	3 months	To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies

Secondary Outcome Measures

Name	Time	Method
Width of Keratinized tissue	3 months	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and it represents the edentulous span measured at the midpoint between teeth on either side of the edentulous space mesiodistally, starting at the buccal edge of the crest of the ridge till the mucogingival line.
Probing depth	3 months	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Clinical attachment loss (CAL)	3 months	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Bleeding on probing	3 months	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt