Tooth Extraction Status NosMucograftNCT02697890
Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft
A study testing FDBA (MinerOss®) + Mucograft® seal and FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) in people with Tooth Extraction Status Nos, run by Tufts University.
Trial summary
The objective of this study is to evaluate clinically and radiographically the effect of Mucograft® seal when used for the ridge preservation procedure in combination with Freeze Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue remodeling after 4 months healing period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- FDBA (MinerOss®) + Mucograft® seal and FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age.
- Have unsalvageable non-adjacent non-molar teeth scheduled for extraction: maxillary incisors, canines, and premolars, and mandibular canines and premolars that require an extraction with ridge preservation planned for delayed implant placement. If a subject has multiple teeth to be extracted, only one tooth will be included in the study.
- Presence of buccal plate at the extraction site as determined by first sectional CBCT scan.
- Patients who are currently treatment planned in the Tufts University School of Dental Medicine (TUSDM) periodontology clinic to receive ridge preservation 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.
- Non-smoker or smoke less than 10 cigarettes per day.
- Not participating in any other 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 (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates, endocrine-induced bone diseases (e.g. hyperparathyroidism), immunosuppressive therapy).
- Have limited mental capacity and unable to give informed consent.
- 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).
- Any known allergy/hypersensitivity to FDBA (contains trace amount of gentamicin, providone-iodine), CS or Mucograft® seal.
- Any known allergy to yeast.
- Have untreated acute infection at surgical site.
Show all 9Show fewer
- Have untreated malignant neoplasm.
- Individuals opposed to having porcine derived materials placed in their mouth due to any personal reasons such as religious reasons.
- Teeth requiring flap reflection for extraction, e.g. deep subgingival caries or fractures.
About this study
Official title: Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft: A Randomized Controlled Clinical Trial and Radiographic Evaluation
The objective of this study is to evaluate clinically and radiographically the effect of Mucograft® seal when used for the ridge preservation procedure in combination with Freeze Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue remodeling after 4 months healing period.
Read the detailed description
One of the serious consequences of single or multiple tooth extraction is the bone resorption that follows, which may create aesthetic problems and compromise future implant placement. Ridge preservation procedures typically use a combination of a scaffold and a membrane. Scaffolds most commonly used are bone grafts; autogenous, allografts, xenografts, and alloplasts. Among these bone grafts, allograft materials such as Demineralized Freeze Dried Bone Allograft (DFDBA) and Freeze Dried Bone Allograft (FDBA) are frequently used in site preservation procedures.
An additional alternative is to use a collagen sponge (CS) in the extraction socket to prevent the infiltration of soft tissues to the lower area and to protect and maintain bone graft materials.
Although ridge preservation has several benefits, it also has several risks and limitations, such as membrane exposure and possible infection, loss or fibrous encapsulation of graft particles, longer healing period prior to implant placement, invasive and technique sensitive procedure, additional cost, and possible soft tissue dehiscence in bone grafted sites compared with non-grafted sites. Therefore, any modifications of the technique that will reduce these risks and limitations would be advantageous.
Mucograft® TM has been specifically designed for soft-tissue regeneration. Its bi-layer structure supports tissue in-growth and regeneration and promotes cellular and extracellular integration within the host tissue. Clinically, this new collagen membrane was associated with a sufficient width of newly formed attached gingiva with coverage of Miller class-I and class-II recession defects. These results suggest that the use of Mucograft® TM in periodontal plastic surgery may provide a viable source of grafting material as an alternative to autogenous and non-autogenous soft tissue graft materials.
This study is a clinical and radiographic, randomized parallel arm comparative evaluation of the addition of Mucograft® seal to FDBA in the ridge preservation procedure. Group A will receive FDBA and a CS. Group B will receive FDBA with Mucograft® seal.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- FDBA (MinerOss®) + Mucograft® seal, FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDBA (MinerOss®) + Mucograft® sealDevice
Collagen matrix membrane for soft-tissue regeneration
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)Device
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) | Active comparator | Interventions:
Procedure: Ridge preservation procedure Receives: Device: FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) |
| FDBA (MinerOss®) + Mucograft® seal | Experimental | Interventions:
Device: Mucograft® seal Procedure: Ridge preservation procedure Receives: Device: FDBA (MinerOss®) + Mucograft® seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Alveolar Bone (mm)
Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans
Measured: 4 months after surgical procedure
Secondary outcomes (3)
Changes in Hard Tissues
Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.
Measured: 4 months after surgical procedure
Changes in Soft Tissues
Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.
Measured: 4 months after surgical procedure
Keratinized Tissue Width (mm)
Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.
Measured: 4 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 posted3 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionDec 2016
- Study completionDec 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 Tooth Extraction Status NosStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Jeong, Tufts University
- Investigators
- Natalie Jeong, DMD, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697890
- Sponsor's protocol ID
- 11360
- Acronym
- Mucograft
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2016
- Last updated
- 31 Mar 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft: A Randomized Controlled Clinical Trial and Radiographic Evaluation
- ClinicalTrials.gov ID
- NCT02697890
- Acronym / sponsor ID
- Mucograft / 11360
- Conditions
- Tooth Extraction Status Nos
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate clinically and radiographically the effect of Mucograft® seal when used for the ridge preservation procedure in combination with Freeze Dried Bone Allograft (FDBA) at the extraction site in terms of hard and soft tissue remodeling after 4 months healing period.
Detailed description
One of the serious consequences of single or multiple tooth extraction is the bone resorption that follows, which may create aesthetic problems and compromise future implant placement. Ridge preservation procedures typically use a combination of a scaffold and a membrane. Scaffolds most commonly used are bone grafts; autogenous, allografts, xenografts, and alloplasts. Among these bone grafts, allograft materials such as Demineralized Freeze Dried Bone Allograft (DFDBA) and Freeze Dried Bone Allograft (FDBA) are frequently used in site preservation procedures.
An additional alternative is to use a collagen sponge (CS) in the extraction socket to prevent the infiltration of soft tissues to the lower area and to protect and maintain bone graft materials.
Although ridge preservation has several benefits, it also has several risks and limitations, such as membrane exposure and possible infection, loss or fibrous encapsulation of graft particles, longer healing period prior to implant placement, invasive and technique sensitive procedure, additional cost, and possible soft tissue dehiscence in bone grafted sites compared with non-grafted sites. Therefore, any modifications of the technique that will reduce these risks and limitations would be advantageous.
Mucograft® TM has been specifically designed for soft-tissue regeneration. Its bi-layer structure supports tissue in-growth and regeneration and promotes cellular and extracellular integration within the host tissue. Clinically, this new collagen membrane was associated with a sufficient width of newly formed attached gingiva with coverage of Miller class-I and class-II recession defects. These results suggest that the use of Mucograft® TM in periodontal plastic surgery may provide a viable source of grafting material as an alternative to autogenous and non-autogenous soft tissue graft materials.
This study is a clinical and radiographic, randomized parallel arm comparative evaluation of the addition of Mucograft® seal to FDBA in the ridge preservation procedure. Group A will receive FDBA and a CS. Group B will receive FDBA with Mucograft® seal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) | Active comparator | Device: FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)Interventions: Procedure: Ridge preservation procedure |
| FDBA (MinerOss®) + Mucograft® seal | Experimental | Device: FDBA (MinerOss®) + Mucograft® sealInterventions: Device: Mucograft® seal Procedure: Ridge preservation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years of age.
- Have unsalvageable non-adjacent non-molar teeth scheduled for extraction: maxillary incisors, canines, and premolars, and mandibular canines and premolars that require an extraction with ridge preservation planned for delayed implant placement. If a subject has multiple teeth to be extracted, only one tooth will be included in the study.
- Presence of buccal plate at the extraction site as determined by first sectional CBCT scan.
- Patients who are currently treatment planned in the Tufts University School of Dental Medicine (TUSDM) periodontology clinic to receive ridge preservation 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.
Key exclusion criteria (9 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 (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates, endocrine-induced bone diseases (e.g. hyperparathyroidism), immunosuppressive therapy).
- Have limited mental capacity and unable to give informed consent.
- 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).
- Any known allergy/hypersensitivity to FDBA (contains trace amount of gentamicin, providone-iodine), CS or Mucograft® seal.
- Any known allergy to yeast.
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 |
|---|---|---|
| FDBA (MinerOss®) + Mucograft® sealCollagen matrix membrane for soft-tissue regeneration | Device | FDBA (MinerOss®) + Mucograft® seal |
| FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)Standard of Care | Device | FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) |
Primary outcome
Changes in Alveolar Bone (mm)
Time frame: 4 months after surgical procedure
Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans
3 secondary outcomes
Changes in Hard Tissues
Time frame: 4 months after surgical procedure
Changes in Soft Tissues
Time frame: 4 months after surgical procedure
Keratinized Tissue Width (mm)
Time frame: 4 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 31 Mar 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.
Natalie Jeong, DMD principal investigator
Tufts University School of Dental Medicine
Questions about this trial
What is this clinical trial studying?
A study testing FDBA (MinerOss®) + Mucograft® seal and FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) in people with Tooth Extraction Status Nos, run by Tufts University.
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 7 inclusion and 9 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 16 May 2017). 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?
Changes in Alveolar Bone (mm) (time frame: 4 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 31 Mar 2020.