Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

NCT04214041 | Completed

• 1 other identifier: fat vs subepithelial CT graft
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (12)

• Probing depth

  1 month

• Probing depth

  2 months

• Probing depth

  3 months

• Clinical attachment loss (CAL)

  1 month

• Clinical attachment loss (CAL)

  2 months

Study Arms (2)

Autologous fat grafting

EXPERIMENTAL

Other: Autologous fat grafting

Sub-epithelial connective tissue graft

ACTIVE COMPARATOR

Other: Sub-epithelial connective tissue graft

Interventions

Autologous fat grafting OTHER

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.

Autologous fat grafting

Sub-epithelial connective tissue graft OTHER

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.

Sub-epithelial connective tissue graft

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (9)

• 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.

  PMID: 12423299 BACKGROUND

• 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.

  PMID: 24720375 BACKGROUND

• 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.

  PMID: 28107560 BACKGROUND

• 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.

  PMID: 24163528 BACKGROUND

• 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.

  PMID: 23732072 BACKGROUND

• 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.

  PMID: 29334403 BACKGROUND

• 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.

  PMID: 24341747 BACKGROUND

• 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.

  PMID: 17590160 BACKGROUND

• 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.

  PMID: 19419446 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yasmine Gaweesh, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Maha A Abou Khadr, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Hussein S Abulhassan, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY CHAIR

• Nesma M Khalil, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither the operator nor the participants could be blinded to the treatment type as the intervention procedures were markedly different between test and control groups. To enable blinding during outcome assessment, the stereolithography (STL) files of digitized casts were given a code different from that of the allocation procedure and were kept confidential. The volumetric analysis was performed and the groupings were shared with the biostatistician as groups A and B. Only during the interpretation the codes and groups were translated into test and control groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: December 17, 2018
• Primary Completion: June 25, 2019
• Study Completion: September 11, 2019
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)