CompletedNCT02697890MucograftUpdated Mar 31, 2020Results posted

Effect of Mucograft® Seal on Post-extraction Ridge Preservation Using Bone Allograft

An interventional study of FDBA (MinerOss®) + Mucograft® seal and FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) in Tooth Extraction Status Nos, sponsored by Tufts University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by Tufts University · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 9 months after the study started (first participant enrolled May 2015, registered Feb 2016).

Phase: Not applicable
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Tooth Extraction Status Nos

In context

Lead sponsor

Tufts University is the lead sponsor of 228 studies on the registry; 25 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 28 participants (actual)

Study arms

Active comparator
FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)
Interventions: Procedure: Ridge preservation procedure
Device: FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)
Experimental
FDBA (MinerOss®) + Mucograft® seal
Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure
Device: FDBA (MinerOss®) + Mucograft® seal

Interventions

DeviceFDBA (MinerOss®) + Mucograft® seal
Collagen matrix membrane for soft-tissue regeneration
DeviceFDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)
Standard of Care

What researchers measure

Primary outcomes

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
Time frame: 4 months after surgical procedure

Secondary outcomes

Changes in Hard Tissues
Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.
Time frame: 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.
Time frame: 4 months after surgical procedure
Keratinized Tissue Width (mm)
Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.
Time frame: 4 months after surgical procedure

Results

Posted May 16, 2017

Participant flow

Participant flow — Overall Study
Milestone	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal
Started	14	14
Completed	14	14
Not completed	0	0

Outcome measures

PrimaryChanges 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

Time frame:: 4 months after surgical procedure
Reported as:: Mean · mm

Changes in Alveolar Bone (mm)
mm	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal
Changes in Alveolar Bone (mm)	-1.47 ± 1.29	-1.21 ± 1.22

SecondaryChanges in Hard Tissues

Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.

Time frame:: 4 months after surgical procedure
Reported as:: Mean · mm

Changes in Hard Tissues
mm	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal
Changes in Hard Tissues	-0.79 ± 3.07	-0.30 ± 1.09

SecondaryChanges in Soft Tissues

Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.

Time frame:: 4 months after surgical procedure
Reported as:: Mean · mm

Changes in Soft Tissues
mm	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal
Changes in Soft Tissues	0.59 ± 1.28	0.90 ± 0.90

SecondaryKeratinized Tissue Width (mm)

Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.

Time frame:: 4 months after surgical procedure
Reported as:: Mean · mm

Keratinized Tissue Width (mm)
mm	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal
Keratinized Tissue Width (mm)	-0.08 ± 1.24	-0.08 ± 0.54

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	—	0/14 (0%)	0/14 (0%)
FDBA (MinerOss®) + Mucograft® Seal	—	0/14 (0%)	0/14 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal	Total
Mean	55.6 (30 to 74)	55.1 (25 to 80)	55.4 (25 to 80)

Sex: Female, Male
Sex: Female, Male(Participants)	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal	Total
Female	7	4	11
Male	7	10	17

Region of Enrollment
Region of Enrollment(participants)	FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)	FDBA (MinerOss®) + Mucograft® Seal	Total
United States	14	14	28

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02697890
Lead sponsor: Tufts University
Responsible party: Natalie Jeong (Associate Professor, Tufts University) — Principal investigator
First posted: Mar 3, 2016
Start date: May 2015
Primary completion: Dec 2016
Completion: Dec 2016
Results posted: May 16, 2017
Last update: Mar 31, 2020

Study contacts

Natalie Jeong, DMD

principal investigator · Tufts University School of Dental Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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