Partial EdentulismNCT01808794
Comparison of Two Different Membranes
A study testing Mucograft and Dynamatrix in people with Partial Edentulism, run by Tufts University at 1 site in United States.
Trial summary
The purpose of the study is to compare one material called "Mucograft" with another material called "Dynamatrix." These materials are used as a type of a barrier (made from pig material also known as porcine material) in a preservation technique to increase the thickness and width of tissues at a tooth extraction… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Mucograft and Dynamatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be at least 18 years of age.
- Have unsalvageable non-adjacent non-molar teeth: maxillary incisors, canines, and premolars, and mandibular canines and premolars that require an extraction with bone augmentation planned for delayed implant placement. If a subject has multiple teeth to be extracted, only one tooth will be included in the study.
- Patients who are currently treatment planned in the Tufts University School of Dental Medicine (TUSDM) periodontology clinic to receive bone augmentation and delayed implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
- Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding.
- Smoke less than 10 cigarettes per day.
- Not participating in any other dental research study for the duration of this study.
Who cannot join
- Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension, recent myocardial infarction (within 6 months of enrollment), poorly controlled diabetes, HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
- Have a history of severe psychological conditions or limited mental capacity.
- Be a pregnant or lactating female (self-reported) (following TUSDM periodontology clinic guidelines elective surgical procedures and radiographs/CBCT scans are usually postponed until after delivery).
- Individuals opposed to having porcine derived materials placed in their mouth.
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: Clinical, Radiographic, and Histological Comparison of Healing After Alveolar Ridge Preservation Using Bone Allograft With Two Different Xenogeneic Membranes
The purpose of the study is to compare one material called "Mucograft" with another material called "Dynamatrix." These materials are used as a type of a barrier (made from pig material also known as porcine material) in a preservation technique to increase the thickness and width of tissues at a tooth extraction site. The investigators want to see if one works better than the other or if they work equally as well. These materials are made up of collagens, which are naturally occurring proteins found in the skin, specifically connective tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of fewer collagens. These materials have been given something called a 510(k) status by the FDA. This means that the FDA determines them to be equivalent to another product that they have previously approved. You will be put into one of two groups at random, and will not know which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one of the two groups. You will either be in a group using Mucograft or in a group using Dynamatrix. Both of these materials are regularly used in the dental clinics.
Read the detailed description
- Aim/Hypothesis/Objective The objective of this study is to compare two different membranes, Mucograft and Dynamatrix, clinically, radiographically, and histologically when used for the ridge preservation procedure in combination with bone allograft at the extraction site in terms of soft and hard tissue remodeling after 4 months healing period.
Hypothesis
- MucograftTM will exhibit greater increase or preservation of the thickness and width of keratinized tissue than DynamatrixTM at the extraction site.
- MucograftTM will exhibit greater preservation of the alveolar bone width and height than DynamatrixTM at the extraction site.
- MucograftTM will exhibit greater preservation of the soft and hard tissue height than DynamatrixTM at the adjacent teeth.
- MucograftTM will exhibit a better outcome than DynamatrixTM in the histological and histomorphometric results of the soft and hard tissue healing.
Specific Aims
- Primary aim The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.
- Secondary aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
- Changes of the alveolar bone height and width at the extraction site.
- Changes of the soft and hard tissues at the adjacent teeth.
- Histological and histomorphometric assessment of the soft and hard tissue healing at the extraction site.
- Conditions
- Partial Edentulism
- Being tested
- Mucograft, Dynamatrix
- Keywords
- membranes, Mucograft, Dynamatrixw, ridge, preservation, bone, allograft, extraction, site, healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MucograftDevice
Also called 510(k) #K073711
Mucograft Collagen Matrix
DynamatrixDevice
Also called 510(k) #K082058
Dynamatrix
| Study group | Role | What they receive |
|---|---|---|
| Mucograft | Active comparator | Placement of randomized membrane on half of subjects Mucograft Receives: Device: Mucograft |
| Dynamatrix | Active comparator | Placement of randomized membrane on half of subjects Dynamatrix Membrane Placement Receives: Device: Dynamatrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Barrier Membranes by Examining Keratinized Tissue
The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.
Measured: 4-6 Months after surgical procedure
Secondary outcomes (1)
Alveolar Bone Height
Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone height at the extraction site.
Measured: 4-6 Months after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial EdentulismStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Hanley, DMD, Principal investigator, TUSDMYoungsoo Kim, DDS, Study director, TUSDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808794
- Sponsor's protocol ID
- TUSDM10551
- Other IDs
- 10551
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2013
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic, and Histological Comparison of Healing After Alveolar Ridge Preservation Using Bone Allograft With Two Different Xenogeneic Membranes
- ClinicalTrials.gov ID
- NCT01808794
- Acronym / sponsor ID
- TUSDM10551
- Conditions
- Partial Edentulism
- Keywords
- membranes, Mucograft, Dynamatrixw, ridge, preservation, bone, allograft, extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 19 Feb 2020
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 the study is to compare one material called "Mucograft" with another material called "Dynamatrix." These materials are used as a type of a barrier (made from pig material also known as porcine material) in a preservation technique to increase the thickness and width of tissues at a tooth extraction site. The investigators want to see if one works better than the other or if they work equally as well. These materials are made up of collagens, which are naturally occurring proteins found in the skin, specifically connective tissue. Dynamatrix is made up of many types of collagens whereas Mucograft is only made of fewer collagens. These materials have been given something called a 510(k) status by the FDA. This means that the FDA determines them to be equivalent to another product that they have previously approved. You will be put into one of two groups at random, and will not know which one you are in. Like flipping a coin, you will have a 50/50 chance to be in either one of the two groups. You will either be in a group using Mucograft or in a group using Dynamatrix. Both of these materials are regularly used in the dental clinics.
Detailed description
- Aim/Hypothesis/Objective The objective of this study is to compare two different membranes, Mucograft and Dynamatrix, clinically, radiographically, and histologically when used for the ridge preservation procedure in combination with bone allograft at the extraction site in terms of soft and hard tissue remodeling after 4 months healing period.
Hypothesis
- MucograftTM will exhibit greater increase or preservation of the thickness and width of keratinized tissue than DynamatrixTM at the extraction site.
- MucograftTM will exhibit greater preservation of the alveolar bone width and height than DynamatrixTM at the extraction site.
- MucograftTM will exhibit greater preservation of the soft and hard tissue height than DynamatrixTM at the adjacent teeth.
- MucograftTM will exhibit a better outcome than DynamatrixTM in the histological and histomorphometric results of the soft and hard tissue healing.
Specific Aims
- Primary aim The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.
- Secondary aims
The secondary aims are to compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to:
- Changes of the alveolar bone height and width at the extraction site.
- Changes of the soft and hard tissues at the adjacent teeth.
- Histological and histomorphometric assessment of the soft and hard tissue healing at the extraction site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucograft | Active comparator | Device: MucograftPlacement of randomized membrane on half of subjects Mucograft |
| Dynamatrix | Active comparator | Device: DynamatrixPlacement of randomized membrane on half of subjects Dynamatrix Membrane Placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age.
- Have unsalvageable non-adjacent non-molar teeth: maxillary incisors, canines, and premolars, and mandibular canines and premolars that require an extraction with bone augmentation planned for delayed implant placement. If a subject has multiple teeth to be extracted, only one tooth will be included in the study.
- Patients who are currently treatment planned in the Tufts University School of Dental Medicine (TUSDM) periodontology clinic to receive bone augmentation and delayed implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
- Display no evidence of acute periodontal infection: e.g., abscess, suppuration, severe swelling and/or spontaneous bleeding.
- Smoke less than 10 cigarettes per day.
Key exclusion criteria (4 listed)
- Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension, recent myocardial infarction (within 6 months of enrollment), poorly controlled diabetes, HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
- Have a history of severe psychological conditions or limited mental capacity.
- Be a pregnant or lactating female (self-reported) (following TUSDM periodontology clinic guidelines elective surgical procedures and radiographs/CBCT scans are usually postponed until after delivery).
- Individuals opposed to having porcine derived materials placed in their mouth.
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 |
|---|---|---|
| MucograftAlso: 510(k) #K073711Mucograft Collagen Matrix | Device | Mucograft |
| DynamatrixAlso: 510(k) #K082058Dynamatrix | Device | Dynamatrix |
Primary outcome
Compare Barrier Membranes by Examining Keratinized Tissue
Time frame: 4-6 Months after surgical procedure
The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.
1 secondary outcome
Alveolar Bone Height
Time frame: 4-6 Months after surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Hanley, DMD principal investigator
TUSDM
Youngsoo Kim, DDS study director
TUSDM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mucograft and Dynamatrix in people with Partial Edentulism, 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 6 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: finished, as of the sponsor's last update on 19 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Compare Barrier Membranes by Examining Keratinized Tissue (time frame: 4-6 Months after surgical procedure). 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 19 Feb 2020.