Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

Alveolar Bone Loss Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214041
• Other study ID #: fat vs subepithelial CT graft
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: September 11, 2019

Study information

• Verified date: December 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 11, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Other:
• Autologous fat grafting
A fat graft will be aspirated from the abdomen under local anaesthesia and processed using the Microfat grafting technique. Afterwards the fat graft will be injected in the previously created pouch at the recipient site. Then the pouch will be closed using interrupted sutures 5-0 vicryl.
• Sub-epithelial connective tissue graft
A subepithelial connective tissue graft of a size that corresponds to that of the defect will be harvested from the palate using the trap door technique. The donor site will be closed using cross horizontal sling sutures and interrupted sutures 4-0 vicryl. Subsequently, the graft will be inserted in the previously created pouch at the recipient site and secured to the flap using vicryl sutures 5-0. Then the pouch will be closed using interrupted sutures.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10. — View Citation

Alharbi Z, Oplander C, Almakadi S, Fritz A, Vogt M, Pallua N. Conventional vs. micro-fat harvesting: how fat harvesting technique affects tissue-engineering approaches using adipose tissue-derived stem/stromal cells. J Plast Reconstr Aesthet Surg. 2013 Sep;66(9):1271-8. doi: 10.1016/j.bjps.2013.04.015. Epub 2013 Jun 2. — View Citation

Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x. — View Citation

Fickl S, Schneider D, Zuhr O, Hinze M, Ender A, Jung RE, Hurzeler MB. Dimensional changes of the ridge contour after socket preservation and buccal overbuilding: an animal study. J Clin Periodontol. 2009 May;36(5):442-8. doi: 10.1111/j.1600-051X.2009.01381.x. — View Citation

Marwah M, Kulkarni A, Godse K, Abhyankar S, Patil S, Nadkarni N. Fat Ful'fill'ment: A Review of Autologous Fat Grafting. J Cutan Aesthet Surg. 2013 Jul;6(3):132-8. doi: 10.4103/0974-2077.118402. — View Citation

Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23. — View Citation

Schneider D, Ender A, Truninger T, Leutert C, Sahrmann P, Roos M, Schmidlin P. Comparison between clinical and digital soft tissue measurements. J Esthet Restor Dent. 2014 May-Jun;26(3):191-9. doi: 10.1111/jerd.12084. Epub 2013 Dec 17. — View Citation

Windisch SI, Jung RE, Sailer I, Studer SP, Ender A, Hammerle CH. A new optical method to evaluate three-dimensional volume changes of alveolar contours: a methodological in vitro study. Clin Oral Implants Res. 2007 Oct;18(5):545-51. doi: 10.1111/j.1600-0501.2007.01382.x. Epub 2007 Jun 21. — View Citation

Zeltner M, Jung RE, Hammerle CH, Husler J, Thoma DS. Randomized controlled clinical study comparing a volume-stable collagen matrix to autogenous connective tissue grafts for soft tissue augmentation at implant sites: linear volumetric soft tissue changes up to 3 months. J Clin Periodontol. 2017 Apr;44(4):446-453. doi: 10.1111/jcpe.12697. Epub 2017 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric analysis to evaluate soft tissue volume changes	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	1 month
Primary	Volumetric analysis to evaluate soft tissue volume changes	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	2 months
Primary	Volumetric analysis to evaluate soft tissue volume changes	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	3 months
Secondary	Probing depth	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	1 month
Secondary	Probing depth	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	2 months
Secondary	Probing depth	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	3 months
Secondary	Clinical attachment loss (CAL)	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	1 month
Secondary	Clinical attachment loss (CAL)	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	2 months
Secondary	Clinical attachment loss (CAL)	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth	3 months
Secondary	Bleeding on probing	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent	1 month
Secondary	Bleeding on probing	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent	2 months
Secondary	Bleeding on probing	measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent	3 months
Secondary	Width of Keratinized tissue	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.	1 month
Secondary	Width of Keratinized tissue	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.	2 months
Secondary	Width of Keratinized tissue	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.	3 months