Gingival RecessionPhase 4NCT03057730
A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes
A Phase 4 study testing Acellular Dermal Matrix in people with Gingival Recession, run by Tufts University at 1 site in United States.
Trial summary
Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Acellular Dermal Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be current patients of Tufts University School of Dental Medicine
- Subjects with two Miller class I or class II adjacent recessions with a recession height ≥ 2 mm and < 4 mm
- Affected tooth/teeth are anterior- incisors, canines or premolars (except the mandibular central and lateral incisors)
- Healthy subjects with no contraindications to root coverage surgery
- Subjects with full-mouth plaque index<1 and gingival index<1, calculated as the average value of plaque index and gingival index
Who cannot join
- Presence of adjacent defects, whose gingival thickness values place them in a different category other than thick or thin biotype
- Areas that have previously been treated with root coverage surgeries
- Subjects with a known hypersensitivity to polysorbate 20 (contraindicated with the use of Alloderm®)
- Subject smokes more than 5 cigarettes per day
- Subjects with systemic conditions which influence wound healing
- Subjects that are pregnant or lactating
- Subjects with a condition causing immunosuppression, or currently taking immunosuppressant medications
- Teeth with severe occlusal interferences, deep cervical lesions, or large restorations whose margins impinge on the cement-enamel junction or make identification of this landmark impossible
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Acellular Dermal Matrix Combined With Coronally Advanced Flap in the Treatment of Multiple Recession Defects in Thin Versus Thick Periodontal Biotype Population: A Controlled Clinical Investigation
Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years.
However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.
Read the detailed description
The study aim is to evaluate and compare the use of acellular dermal matrix, a material used for treating gum recession, in two study populations, namely thin or thick gingival biotype. Short term outcomes and the long term stability of ADM in recession repair between thick and thin biotypes will be evaluated.
There will be two study groups, namely thin and thick groups. The included subjects will be divided in two groups according to gingival thickness: Thin gingival biotype group (TnB): < 0.8 mm, thick gingival biotype group (TkB) ≥ 0.8 mm. Each subject will be in one of the two groups only.
Randomization will not be used to assign the subjects to the study groups, because the intervention will be the same for both groups, namely ADM applied beneath a coronally advanced flap.
The short term (3 months, 6 months post-surgery) outcomes and the longer term (12 months, 24 months and 48 months post-surgery) outcomes will further be compared within the groups and between the groups.
- Conditions
- Gingival Recession
- Being tested
- Acellular Dermal Matrix
- Keywords
- acellular dermal matrix
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixBiological
Also called Alloderm®
ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Thin Biotype | Experimental | Gingival thickness < 0.8 mm
Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured.
Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery. Receives: Biological: Acellular Dermal Matrix |
| Group 2: Thick Biotype | Experimental | Gingival thickness ≥ 0.8 mm
Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured.
Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery. Receives: Biological: Acellular Dermal Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Root Coverage
Root coverage will be measured in mm using a probe and digital caliper. Mean root coverage will be measured per patient by averaging the two study teeth. Change in mean root coverage for the primary outcome will be assessed by the difference between the baseline mean root coverage and the final mean root coverage at 48 months post surgery.
Measured: Up to 48 months post surgery
Secondary outcomes (7)
Change in Clinical Probing Depth (CPD)
Measured: Up to 48 months post surgery
Change in Clinical Attachment Level (CAL)
CAL will be measured from the base of the pocket to the cementoenamel junction (CEJ) in mm using a probe and digital caliper. Change in CAL will be assessed from baseline to 48 months post surgery.
Measured: Up to 48 months post surgery
Change in Recession Height (RH)
Measured: Up to 48 months post surgery
Change in Recession Width (RW)
Measured: Up to 48 months post surgery
Change in Keratinized Tissue Width
Measured: Up to 48 months post surgery
Change in Gingival Thickness (GT)
Measured: Up to 48 months post surgery
Complete Root Coverage (CRC)
CRC will be assessed using descriptive statistics (# subjects with CRC out of the total sample)
Measured: Up to 48 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startAug 2015
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wai Cheung, DMD, MS, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057730
- Sponsor's protocol ID
- 11692
- Status last verified
- Aug 2024
- First submitted
- 18 Jan 2017
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Dermal Matrix Combined With Coronally Advanced Flap in the Treatment of Multiple Recession Defects in Thin Versus Thick Periodontal Biotype Population: A Controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT03057730
- Acronym / sponsor ID
- 11692
- Conditions
- Gingival Recession
- Keywords
- acellular dermal matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Feb 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.
Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years.
However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.
Detailed description
The study aim is to evaluate and compare the use of acellular dermal matrix, a material used for treating gum recession, in two study populations, namely thin or thick gingival biotype. Short term outcomes and the long term stability of ADM in recession repair between thick and thin biotypes will be evaluated.
There will be two study groups, namely thin and thick groups. The included subjects will be divided in two groups according to gingival thickness: Thin gingival biotype group (TnB): < 0.8 mm, thick gingival biotype group (TkB) ≥ 0.8 mm. Each subject will be in one of the two groups only.
Randomization will not be used to assign the subjects to the study groups, because the intervention will be the same for both groups, namely ADM applied beneath a coronally advanced flap.
The short term (3 months, 6 months post-surgery) outcomes and the longer term (12 months, 24 months and 48 months post-surgery) outcomes will further be compared within the groups and between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Thin Biotype | Experimental | Biological: Acellular Dermal MatrixGingival thickness < 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery. |
| Group 2: Thick Biotype | Experimental | Biological: Acellular Dermal MatrixGingival thickness ≥ 0.8 mm Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured. Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be current patients of Tufts University School of Dental Medicine
- Subjects with two Miller class I or class II adjacent recessions with a recession height ≥ 2 mm and < 4 mm
- Affected tooth/teeth are anterior- incisors, canines or premolars (except the mandibular central and lateral incisors)
- Healthy subjects with no contraindications to root coverage surgery
- Subjects with full-mouth plaque index<1 and gingival index<1, calculated as the average value of plaque index and gingival index
Key exclusion criteria (8 listed)
- Presence of adjacent defects, whose gingival thickness values place them in a different category other than thick or thin biotype
- Areas that have previously been treated with root coverage surgeries
- Subjects with a known hypersensitivity to polysorbate 20 (contraindicated with the use of Alloderm®)
- Subject smokes more than 5 cigarettes per day
- Subjects with systemic conditions which influence wound healing
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 |
|---|---|---|
| Acellular Dermal MatrixAlso: Alloderm®ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains. | Biological | Group 1: Thin Biotype, Group 2: Thick Biotype |
Primary outcome
Change in Mean Root Coverage
Time frame: Up to 48 months post surgery
Root coverage will be measured in mm using a probe and digital caliper. Mean root coverage will be measured per patient by averaging the two study teeth. Change in mean root coverage for the primary outcome will be assessed by the difference between the baseline mean root coverage and the final mean root coverage at 48 months post surgery.
7 secondary outcomes
Change in Clinical Probing Depth (CPD)
Time frame: Up to 48 months post surgery
Change in Clinical Attachment Level (CAL)
Time frame: Up to 48 months post surgery
Change in Recession Height (RH)
Time frame: Up to 48 months post surgery
Change in Recession Width (RW)
Time frame: Up to 48 months post surgery
Change in Keratinized Tissue Width
Time frame: Up to 48 months post surgery
Change in Gingival Thickness (GT)
Time frame: Up to 48 months post surgery
Complete Root Coverage (CRC)
Time frame: Up to 48 months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Wai Cheung, DMD, MS principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acellular Dermal Matrix in people with Gingival Recession, run by Tufts University 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Change in Mean Root Coverage (time frame: Up to 48 months post surgery). 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 20 Aug 2024.