Gingival RecessionNCT05956496
Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices
A study testing Allograft Material ADM-S and Allograft Material ADM-D in people with Gingival Recession, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Allograft Material ADM-S and Allograft Material ADM-D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 9 Apr 2024
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between age 18 and 89
- Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth)
- Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report.
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
Who cannot join
- Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- Pregnant women or women intending to become pregnant during study period.
- Smokers who smoke > 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.
Read the detailed description
Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.
- Conditions
- Gingival Recession
- Being tested
- Allograft Material ADM-S, Allograft Material ADM-D
- Keywords
- Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft Material ADM-SOther
Also called Acellular Dermal Matrix-superficial
A piece of the allograft material (ADM-D) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.
Allograft Material ADM-DOther
Also called Acellular Dermal Matrix-deep
A piece of the allograft material (ADM-S) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S) | Placebo comparator | A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts. Receives: Other: Allograft Material ADM-S |
| Test Group:Acellular Dermal Matrix - Deep cut (ADM-D) | Active comparator | The use of a deep cut ADM for root coverage gingival plastic procedures. Receives: Other: Allograft Material ADM-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage root coverage
Measured as change in percentage root coverage
Measured: Baseline to 12 months
Keratinized tissue width
Measured as change in keratinized tissue width
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start3 Oct 2023
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Why it stopped: The study team experienced an increased number of complications than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies 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 is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Palaiologou-Gallis, DDS, MS, The University of Texas Health Science Center at San Antonio
- Investigators
- Angela Palaiologou-Gallis, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956496
- Sponsor's protocol ID
- HSC20230466H
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2023
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected de-identified Individual Participant data (IPD) that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
- ClinicalTrials.gov ID
- NCT05956496
- Acronym / sponsor ID
- HSC20230466H
- Conditions
- Gingival Recession
- Keywords
- Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study team experienced an increased number of complications than expected
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 21 Jul 2023 (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.
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.
Detailed description
Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
| Arm | Type | Receives |
|---|---|---|
| Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S) | Placebo comparator | Other: Allograft Material ADM-SA commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts. |
| Test Group:Acellular Dermal Matrix - Deep cut (ADM-D) | Active comparator | Other: Allograft Material ADM-DThe use of a deep cut ADM for root coverage gingival plastic procedures. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between age 18 and 89
- Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth)
- Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report.
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
Key exclusion criteria (4 listed)
- Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- Pregnant women or women intending to become pregnant during study period.
- Smokers who smoke > 10 cigarettes per day
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 |
|---|---|---|
| Allograft Material ADM-SAlso: Acellular Dermal Matrix-superficialA piece of the allograft material (ADM-D) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure. | Other | Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S) |
| Allograft Material ADM-DAlso: Acellular Dermal Matrix-deepA piece of the allograft material (ADM-S) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure. | Other | Test Group:Acellular Dermal Matrix - Deep cut (ADM-D) |
Primary outcome
Percentage root coverage
Time frame: Baseline to 12 months
Measured as change in percentage root coverage
Keratinized tissue width
Time frame: Baseline to 12 months
Measured as change in keratinized tissue width
Results and safety
The study was stopped early (reason given: The study team experienced an increased number of complications than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: Yes. All collected de-identified Individual Participant data (IPD) that underlie results in a publication
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Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
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Gingival Recession
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.
Angela Palaiologou-Gallis, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allograft Material ADM-S and Allograft Material ADM-D in people with Gingival Recession, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Apr 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: The study team experienced an increased number of complications than expected). Results are not available in the source record.
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?
Percentage root coverage (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2024.