Gingival RecessionNCT03467802
Collagen Matrix With and Without Enamel Matrix Derivative
An observational study of Gingival Recession, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession
- What is being tested?
- enamel matrix derivative and Porcine collagen matrix
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Participants must meet health eligibility requirements and not have any conditions that will exclude them from the study (see exclusion criteria below). Females of reproductive age will be asked to submit urine samples for pregnancy testing prior to surgery. Urine HCG tests will be conducted in the Department of Periodontics in accordance with WRNNMC Bethesda Point of Care Testing Procedures. Pregnant females will be excluded from this study in accordance with standard of care (periodontal surgery is routinely deferred during pregnancy).
Who may be able to join
- Age 18 years or over
- Patient will remain in the Capital region for at least 6 months following the surgical procedure for follow up appointments
- Patient must be otherwise periodontally healthy
- Patient must be systemically healthy (ASA class I or II)
- Patient must have no contraindications to periodontal surgery
- Patient must have demonstrated good oral hygiene (plaque index <1 according to Silness and Löe)
- Paired Miller Class I, II or predictable III recession defects
- Bilateral, facial defects on single-rooted teeth
Who cannot join
- Self-reported history of smoking within previous 6 months
- Does not meet any of the preceding criteria
- Female patients who are pregnant or nursing
- Antibiotic medications taken within the last 6 months
- History of mucogingival surgery at the sites of interest
- Poor plaque control (>25% of sites)
Show all 16Show fewer
- Those with clinically significant systemic disease, which may affect healing (i.e. uncontrolled diabetes or bone metabolic disease)
- Allergy to chlorhexidine gluconate (Peridex)
- Does not sign study consent or HIPAA forms
- Bleeding complications (e.g. hemophilia)
- Warfarin therapy
- History of osteoporosis or taking bisphosphonate medications
- History of radiation therapy in the head and neck area
- Mobile teeth beyond physiologic mobility
- Facial restorations at the site to be treated
- Recession defects that will require more than one 15x20mm Mucograft (per side)
Trial locations and contacts
1 site in 1 country.
Brent Tibbet, DMD contact
United States1 site, 1 recruiting
- Recruiting
Walter Reed NMMC
Bethesda, Maryland, 20814
Ryan A Kaye, DMD, 301-295-2127, ryan.a.kaye.mil@mail.mil
About this study
Official title: Porcine Collagen Matrix With and Without Enamel Matrix Derivative for the Treatment of Gingival Recession Defects
The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession defects. One defect will receive CM + CAF + EMD (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60 similarly sized Miller class I, II, or predictable class III recession defects on single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated. The subjects will be in good health, non-smokers, periodontally healthy with good oral hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects on single-rooted teeth will be in the same subject and measure within 2mm of each other. One defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the control group using only CM + CAF. Clinical measurements will be made using a UNC-15 periodontal probe by calibrated, board certified periodontists and will include: probing depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6 months post-surgery for comparison.
- Conditions
- Gingival Recession
- Being tested
- enamel matrix derivative, Porcine collagen matrix
- Keywords
- Gingival Recession, Enamel Matrix Derivative, Porcine Collagen 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.
enamel matrix derivativeBiological
Also called Emdogain®
Enamel matrix derivative (EMD), sold under the brand name Emdogain®, is an amelogenin derivative of embryonal porcine enamel and is FDA approved for application to root surfaces to treat recession defects. Amelogenins comprise the majority of the proteins in EMD while others such as tuftelin, ameloblastin and amelin make up the remainder. EMD is thought to mimic the role of proteins crucial to cementogenesis and root development, which may promote new gingival attachment to exposed roots. The properties of EMD may favor early healing of the soft tissue and stimulate angiogenesis.
Porcine collagen matrixDevice
Also called Mucograft®
Mucograft® is a bi-layered grafting material composed of Type I and III collagen. It is derived from veterinary certified pigs, sterilized by gamma irradiation and has a low antigenicity in conjunction with good biocompatibility. The material is approximately 2.5-5mm thick and is indicated for root coverage, increasing keratinized tissue, covering of implants placed immediately and alveolar ridge reconstruction. A compact outer layer contributes to protection, structure and allows for better control during suturing; while the inner layer is thick, porous and spongy in nature, providing a suitable environment for early vascularization and promotion of cellular in-growth.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival recession using conventional measurements
Change in gingival recession measurements from baseline to 6 months
Measured: Baseline to 6 months
Change in root coverage using digital analysis
Assessment of surgical outcome by optically scanning stone models captured at baseline to 6 months post-surgery. The digital files will be aligned using global registration and GR recorded by measuring the distance from cemento-enamel junction to the height of the marginal gingiva using computer software. % RC will be calculated by comparing GR at the various times.
Measured: Baseline to 6 months
Change in Probing Depths
Change in Probing Depthmeasurements from baseline to 6 months
Measured: Baseline to 6 months
Change in Clinical Attachment Levels
Change in Clinical Attachment Levels measurements from baseline to 6 months
Measured: Baseline to 6 months
Change in Keratinized Tissue
Change in Keratinized Tissue measurements from baseline to 6 months
Measured: Baseline to 6 months
Secondary outcomes (1)
Comparison of digital vs. conventional measurement
Compare conventional and digital change in gingival recession to assess the two modalities treatment outcomes
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Jan 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion31 Dec 2021 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467802
- Sponsor's protocol ID
- WRNMMC-2017-0123
- Status last verified
- Apr 2019
- First submitted
- 1 Mar 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porcine Collagen Matrix With and Without Enamel Matrix Derivative for the Treatment of Gingival Recession Defects
- ClinicalTrials.gov ID
- NCT03467802
- Acronym / sponsor ID
- WRNMMC-2017-0123
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Enamel Matrix Derivative, Porcine Collagen Matrix
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Mar 2018 (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 purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession defects. One defect will receive CM + CAF + EMD (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60 similarly sized Miller class I, II, or predictable class III recession defects on single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated. The subjects will be in good health, non-smokers, periodontally healthy with good oral hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects on single-rooted teeth will be in the same subject and measure within 2mm of each other. One defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the control group using only CM + CAF. Clinical measurements will be made using a UNC-15 periodontal probe by calibrated, board certified periodontists and will include: probing depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6 months post-surgery for comparison.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants must meet health eligibility requirements and not have any conditions that will exclude them from the study (see exclusion criteria below). Females of reproductive age will be asked to submit urine samples for pregnancy testing prior to surgery. Urine HCG tests will be conducted in the Department of Periodontics in accordance with WRNNMC Bethesda Point of Care Testing Procedures. Pregnant females will be excluded from this study in accordance with standard of care (periodontal surgery is routinely deferred during pregnancy).
Key inclusion criteria (8 listed)
- Age 18 years or over
- Patient will remain in the Capital region for at least 6 months following the surgical procedure for follow up appointments
- Patient must be otherwise periodontally healthy
- Patient must be systemically healthy (ASA class I or II)
- Patient must have no contraindications to periodontal surgery
Key exclusion criteria (16 listed)
- Self-reported history of smoking within previous 6 months
- Does not meet any of the preceding criteria
- Female patients who are pregnant or nursing
- Antibiotic medications taken within the last 6 months
- History of mucogingival surgery at the sites of interest
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 |
|---|---|---|
| enamel matrix derivativeAlso: Emdogain®Enamel matrix derivative (EMD), sold under the brand name Emdogain®, is an amelogenin derivative of embryonal porcine enamel and is FDA approved for application to root surfaces to treat recession defects. Amelogenins comprise the majority of the proteins in EMD while others such as tuftelin, ameloblastin and amelin make up the remainder. EMD is thought to mimic the role of proteins crucial to cementogenesis and root development, which may promote new gingival attachment to exposed roots. The properties of EMD may favor early healing of the soft tissue and stimulate angiogenesis. | Biological | – |
| Porcine collagen matrixAlso: Mucograft®Mucograft® is a bi-layered grafting material composed of Type I and III collagen. It is derived from veterinary certified pigs, sterilized by gamma irradiation and has a low antigenicity in conjunction with good biocompatibility. The material is approximately 2.5-5mm thick and is indicated for root coverage, increasing keratinized tissue, covering of implants placed immediately and alveolar ridge reconstruction. A compact outer layer contributes to protection, structure and allows for better control during suturing; while the inner layer is thick, porous and spongy in nature, providing a suitable environment for early vascularization and promotion of cellular in-growth. | Device | – |
Primary outcome
Change in gingival recession using conventional measurements
Time frame: Baseline to 6 months
Change in gingival recession measurements from baseline to 6 months
Change in root coverage using digital analysis
Time frame: Baseline to 6 months
Assessment of surgical outcome by optically scanning stone models captured at baseline to 6 months post-surgery. The digital files will be aligned using global registration and GR recorded by measuring the distance from cemento-enamel junction to the height of the marginal gingiva using computer software. % RC will be calculated by comparing GR at the various times.
Change in Probing Depths
Time frame: Baseline to 6 months
Change in Probing Depthmeasurements from baseline to 6 months
Change in Clinical Attachment Levels
Time frame: Baseline to 6 months
Change in Clinical Attachment Levels measurements from baseline to 6 months
Change in Keratinized Tissue
Time frame: Baseline to 6 months
Change in Keratinized Tissue measurements from baseline to 6 months
1 secondary outcome
Comparison of digital vs. conventional measurement
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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.
Brent Tibbet, DMD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Recession, run by Walter Reed National Military Medical Center 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 8 inclusion and 16 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 1 Jul 2019. 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.
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?
Contact Ryan A Kaye, DMD (3012952127, ryan.a.kaye.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival recession using conventional measurements (time frame: Baseline to 6 months). The study lists 5 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 1 Jul 2019.