Alveolar Bone LossNCT04214041
Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation
A study testing Autologous fat grafting and Sub-epithelial connective tissue graft in people with Alveolar Bone Loss, run by Nourhan M.Aly at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Autologous fat grafting and Sub-epithelial connective tissue graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Dec 2018to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Alveolar Bone Loss
- Being tested
- Autologous fat grafting, Sub-epithelial connective tissue graft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat graftingOther
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 graftOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous fat grafting | Experimental | Not described Receives: Other: Autologous fat grafting |
| Sub-epithelial connective tissue graft | Active comparator | Not described Receives: Other: Sub-epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months
Secondary outcomes (12)
Probing depth
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 1 month
Probing depth
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 2 months
Probing depth
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 3 months
Clinical attachment loss (CAL)
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 1 month
Clinical attachment loss (CAL)
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 2 months
Clinical attachment loss (CAL)
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) at 6 points around the tooth
Measured: 3 months
Bleeding on probing
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent
Measured: 1 month
Bleeding on probing
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent
Measured: 2 months
Bleeding on probing
measured using Michigan "O" probe with William's calibrations ((Hu-Friedy, Chicago, IL, USA) and recorded as present/absent
Measured: 3 months
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.
Measured: 1 month
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.
Measured: 2 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start17 Dec 2018
- Primary completion25 Jun 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Yasmine Gaweesh, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptMaha A Abou Khadr, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptHussein S Abulhassan, PhD, Study chair, Faculty of Medicine, Alexandria University, EgyptNesma M Khalil, PhD, Study chair, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214041
- Sponsor's protocol ID
- fat vs subepithelial CT graft
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2019
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12423299Akcali 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.
PubMed 24720375Zeltner 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.
PubMed 28107560Marwah 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.
PubMed 24163528Alharbi 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.
PubMed 23732072Rojo 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.
PubMed 29334403Schneider 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.
PubMed 24341747Windisch 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.
PubMed 17590160Fickl 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.
PubMed 19419446
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04214041
- Acronym / sponsor ID
- fat vs subepithelial CT graft
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Autologous fat grafting | Experimental | Other: Autologous fat grafting |
| Sub-epithelial connective tissue graft | Active comparator | Other: Sub-epithelial connective tissue graft |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous fat graftingA 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. | Other | Autologous fat grafting |
| Sub-epithelial connective tissue graftA 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. | Other | Sub-epithelial connective tissue graft |
Primary outcome
Volumetric analysis to evaluate soft tissue volume changes
Time frame: 1 month
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
Volumetric analysis to evaluate soft tissue volume changes
Time frame: 2 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
Volumetric analysis to evaluate soft tissue volume changes
Time frame: 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
12 secondary outcomes
Probing depth
Time frame: 1 month
Probing depth
Time frame: 2 months
Probing depth
Time frame: 3 months
Clinical attachment loss (CAL)
Time frame: 1 month
Clinical attachment loss (CAL)
Time frame: 2 months
Clinical attachment loss (CAL)
Time frame: 3 months
Bleeding on probing
Time frame: 1 month
Bleeding on probing
Time frame: 2 months
Bleeding on probing
Time frame: 3 months
Width of Keratinized tissue
Time frame: 1 month
Width of Keratinized tissue
Time frame: 2 months
Width of Keratinized tissue
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Background: PubMed 12423299Del 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.
- Background: PubMed 24720375Akcali 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.
- Background: PubMed 28107560Zeltner 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.
- Background: PubMed 24163528Marwah 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.
- Background: PubMed 23732072Alharbi 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.
- Background: PubMed 29334403Rojo 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.
- Background: PubMed 24341747Schneider 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.
- Background: PubMed 17590160Windisch 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.
- Background: PubMed 19419446Fickl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmine Gaweesh, PhD principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Maha A Abou Khadr, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Hussein S Abulhassan, PhD study chair
Faculty of Medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous fat grafting and Sub-epithelial connective tissue graft in people with Alveolar Bone Loss, run by Nourhan M.Aly at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric analysis to evaluate soft tissue volume changes (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214041, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.