Gingiva AtrophyNCT03251001
Acellular Dermal Matrix Allograft Versus Free Gingival Graft
A study testing Acellular Dermal Matrix in people with Gingiva Atrophy and Gingivitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingiva Atrophy, Gingivitis
- What is being tested?
- Acellular Dermal Matrix
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 1999to 20 Dec 2017
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
- Miller Class I or II gingival recession
- Absence of radiographic bone loss
- Vital tooth or with adequate endodontic treatment
- Root surfaces without caries
- Good oral hygiene (plaque index < 20%)
Who cannot join
- Allergic to penicillin
- Presenting systemic disease that impede surgical procedure
- Smokers
- Pregnancy
- Intake of calcium channel blockers that cause gingival augmentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial
The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)
- Conditions
- Gingiva Atrophy, Gingivitis
- Being tested
- Control, Acellular Dermal Matrix
- Keywords
- gingiva, keratinized mucosa, gingival graft
- Medical subject headings
- Gingival Recession, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
Acellular Dermal MatrixDevice
Also called allograft
Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Sites receiving a free gingival graft Receives: Procedure: Control |
| Device - Acellular dermal matrix | Experimental | Sites receiving acellular dermal matrix Receives: Device: Acellular Dermal Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
keratinized tissue width
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
Measured: 18 years
Secondary outcomes (3)
Probing depth
Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Measured: 18 years
Attachment level
Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
Measured: 18 years
Recession depth
Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.
Measured: 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Feb 1999
- Primary completion30 Nov 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingiva AtrophyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Split-mouth design. One side of mouth was test group, other side was control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251001
- Sponsor's protocol ID
- BauruSchoolDentistryADM
- Status last verified
- Mar 2018
- First submitted
- 9 Aug 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cummings 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 15974840Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
PubMed 26681852
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03251001
- Acronym / sponsor ID
- BauruSchoolDentistryADM
- Conditions
- Gingiva Atrophy, Gingivitis
- Keywords
- gingiva, keratinized mucosa, gingival graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Feb 1999 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 16 Aug 2017 (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 present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design. One side of mouth was test group, other side was control group.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: ControlSites receiving a free gingival graft |
| Device - Acellular dermal matrix | Experimental | Device: Acellular Dermal MatrixSites receiving acellular dermal matrix |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- absence or deficiency of keratinized tissue (< 1mm) in two homologous contralateral sites of inferior premolars
- Miller Class I or II gingival recession
- Absence of radiographic bone loss
- Vital tooth or with adequate endodontic treatment
- Root surfaces without caries
Key exclusion criteria (5 listed)
- Allergic to penicillin
- Presenting systemic disease that impede surgical procedure
- Smokers
- Pregnancy
- Intake of calcium channel blockers that cause gingival augmentation
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 |
|---|---|---|
| ControlFree epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva | Procedure or surgery | Control |
| Acellular Dermal MatrixAlso: allograftAcellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate | Device | Device - Acellular dermal matrix |
Primary outcome
keratinized tissue width
Time frame: 18 years
Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
3 secondary outcomes
Probing depth
Time frame: 18 years
Attachment level
Time frame: 18 years
Recession depth
Time frame: 18 years
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 9 Mar 2018.
- 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 26681852Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix in people with Gingiva Atrophy and Gingivitis, run by University of Sao Paulo at 1 site in Brazil.
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 9 Mar 2018. 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 Brazil. 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?
keratinized tissue width (time frame: 18 years). 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 NCT03251001, which also lists 2 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 9 Mar 2018.