Gingival Recession, GeneralizedNCT03954028
The Healing of Soft Tissue Augmentation by Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft
A study testing Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation in people with Gingival Recession, Generalized and Graft Reaction, run by University of Florida.
Trial summary
The study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Generalized, Graft Reaction
- What is being tested?
- Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- general healthy
- periodontal healthy (no PD >3mm, no BOP, no mobility at the test site and control site)
- patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics
Who cannot join
- current smoker or smoking history
- taking Antibiotics or medicines within the last 3 months
- past history of gingival soft tissue augmentation/modification surgery
About this study
Official title: The Study on the Healing of Soft Tissue Augmentation by the Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft
The study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. The researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.
Read the detailed description
The investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. It is a split-mouth design: CTG will be used in one side of soft tissue augmentation, and ADM will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. The gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. The collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.
- Conditions
- Gingival Recession, Generalized, Graft Reaction
- Being tested
- Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Punch Biopsy after healing of Gingival Soft Tissue AugmentationProcedure or surgery
Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis.
| Study group | Role | What they receive |
|---|---|---|
| CTG Group | Active comparator | Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the autogenous connective tissue graft (CTG) material will be randomized to transplant to one side of the arch. Receives: Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation |
| ADM Group | Active comparator | The patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the commercial acellular dermal matrix (ADM) materials will be transplanted to the opposite side of the arch with CTG transplants. Receives: Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The histological analysis of the gingival biopsy tissue.
Histological analysis with standard coloration will assess the epithelium and underneath connective tissue within the gingival biopsy tissue. Signs of inflammation (ulcerations, infiltration of neutrophil cells, vessel structure) will be noted.
Measured: Month 3---after the gingival biopsy procedures
Secondary outcomes (2)
The immunohistological analysis of the gingival biopsy.
Immunohistological analysis using specific antibodies will locate the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), and re-innvervation (protein gene product 9.5, calcitonin-related gene product) according to the similar study by Perotto, et al. 2017.
Measured: Month 3---after the gingival biopsy procedures
RT-qPCR analysis of gingival biopsy.
The RT-qPCR analysis will measure the level of expression (compared to the housekeeping gene GAPDH) of RNA specific to the epithelium (collagen IV), the smooth muscle (Smooth muscle actin), re-innvervation (protein gene product 9.5, calcitonin-related gene product) and inflammation (IL-1, IL-6, MMP-8, TNF-alpha).
Measured: Month 3---after the gingival biopsy procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study startMar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Withdrawn with IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, GeneralizedStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Implants Manufacturing GmbH
- Responsible party
- Sponsor
- Investigators
- Jia Chang, DDS, MS, PhD, Principal investigator, University of Florida College of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954028
- Sponsor's protocol ID
- IRB201900963
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data sets are to be shared include all collected IPD, all IPD that underlie results in a publication
Publications
McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
PubMed 24597764Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.
PubMed 15974840de Resende DRB, Greghi SLA, Siqueira AF, Benfatti CAM, Damante CA, Ragghianti Zangrando MS. Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):539-550. doi: 10.1007/s00784-018-2470-6. Epub 2018 Apr 30.
PubMed 29713889Menceva Z, Dimitrovski O, Popovska M, Spasovski S, Spirov V, Petrushevska G. Free Gingival Graft versus Mucograft: Histological Evaluation. Open Access Maced J Med Sci. 2018 Mar 27;6(4):675-679. doi: 10.3889/oamjms.2018.127. eCollection 2018 Apr 15.
PubMed 29731940Wei PC, Laurell L, Lingen MW, Geivelis M. Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. J Periodontol. 2002 Mar;73(3):257-65. doi: 10.1902/jop.2002.73.3.257.
PubMed 11922254Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.
PubMed 28609502
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Healing of Soft Tissue Augmentation by the Acellular Dermal Matrix and Autogenous Subepithelial Connective Tissue Graft
- ClinicalTrials.gov ID
- NCT03954028
- Acronym / sponsor ID
- IRB201900963
- Conditions
- Gingival Recession, Generalized, Graft Reaction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn with IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Dentsply Implants Manufacturing GmbH
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 17 May 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 study team proposes to prospectively compare the healing outcomes of autogenous soft tissue connective tissue graft (CTG) and Acellular dermis matrix (ADM) in a split-mouth design study for patients requiring modification of gingival soft tissue biotype. The researchers aim to investigate the earlier phase of graft healing after the grafting surgery by biopsy histology and by examining the alteration of gene profile during the healing of gingival tissue healing by molecular cell biological techniques.
Detailed description
The investigators will perform a prospective clinical randomized controlled trial, and recruit 12 patients who need gingival soft tissue augmentation. It is a split-mouth design: CTG will be used in one side of soft tissue augmentation, and ADM will be used on the other side. 3 months after graft healing, clinical measurements including soft tissue thickness, transparency visualization, tissue profile record with impression cast study model, and digital photography of tissue will be performed. The gingival punch biopsies ( 2mm diameters) will be performed in both sides of grafting areas under the local oral anesthesia injection. The collected tissue will be split into two halves, one for histological examination, and another half for gene analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half.
| Arm | Type | Receives |
|---|---|---|
| CTG Group | Active comparator | Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue AugmentationPatients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the autogenous connective tissue graft (CTG) material will be randomized to transplant to one side of the arch. |
| ADM Group | Active comparator | Procedure: Gingival Punch Biopsy after healing of Gingival Soft Tissue AugmentationThe patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. In this group, the commercial acellular dermal matrix (ADM) materials will be transplanted to the opposite side of the arch with CTG transplants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- general healthy
- periodontal healthy (no PD >3mm, no BOP, no mobility at the test site and control site)
- patients identified need gingival biotype modification (need for increased tissue thickness) during the periodontal exam or referred from orthodontics
Key exclusion criteria (3 listed)
- current smoker or smoking history
- taking Antibiotics or medicines within the last 3 months
- past history of gingival soft tissue augmentation/modification surgery
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 |
|---|---|---|
| Gingival Punch Biopsy after healing of Gingival Soft Tissue AugmentationPatients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis. | Procedure or surgery | ADM Group, CTG Group |
Primary outcome
The histological analysis of the gingival biopsy tissue.
Time frame: Month 3---after the gingival biopsy procedures
Histological analysis with standard coloration will assess the epithelium and underneath connective tissue within the gingival biopsy tissue. Signs of inflammation (ulcerations, infiltration of neutrophil cells, vessel structure) will be noted.
2 secondary outcomes
The immunohistological analysis of the gingival biopsy.
Time frame: Month 3---after the gingival biopsy procedures
RT-qPCR analysis of gingival biopsy.
Time frame: Month 3---after the gingival biopsy procedures
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 24597764McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.
- Background: PubMed 15974840Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.
- Background: PubMed 29713889de Resende DRB, Greghi SLA, Siqueira AF, Benfatti CAM, Damante CA, Ragghianti Zangrando MS. Acellular dermal matrix allograft versus free gingival graft: a histological evaluation and split-mouth randomized clinical trial. Clin Oral Investig. 2019 Feb;23(2):539-550. doi: 10.1007/s00784-018-2470-6. Epub 2018 Apr 30.
- Background: PubMed 29731940Menceva Z, Dimitrovski O, Popovska M, Spasovski S, Spirov V, Petrushevska G. Free Gingival Graft versus Mucograft: Histological Evaluation. Open Access Maced J Med Sci. 2018 Mar 27;6(4):675-679. doi: 10.3889/oamjms.2018.127. eCollection 2018 Apr 15.
- Background: PubMed 11922254Wei PC, Laurell L, Lingen MW, Geivelis M. Acellular dermal matrix allografts to achieve increased attached gingiva. Part 2. A histological comparative study. J Periodontol. 2002 Mar;73(3):257-65. doi: 10.1902/jop.2002.73.3.257.
- Background: PubMed 28609502Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.
- Individual participant dataSharing planned: Yes. The individual participant data sets are to be shared include all collected IPD, all IPD that underlie results in a publication
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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.
Jia Chang, DDS, MS, PhD principal investigator
University of Florida College of Dentistry, Department of Periodontology
Questions about this trial
What is this clinical trial studying?
A study testing Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation in people with Gingival Recession, Generalized and Graft Reaction, run by University of Florida.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The histological analysis of the gingival biopsy tissue. (time frame: Month 3---after the gingival biopsy procedures). 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 NCT03954028, which also lists 6 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 23 Apr 2021.