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

NCT02697890 | Completed Results

• 1 other identifier: 11360
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• 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

  4 months after surgical procedure

Secondary Outcomes (3)

• Changes in Hard Tissues

  4 months after surgical procedure

• Changes in Soft Tissues

  4 months after surgical procedure

• Keratinized Tissue Width (mm)

  4 months after surgical procedure

Study Arms (2)

FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)

ACTIVE COMPARATOR

Interventions: Procedure: Ridge preservation procedure

Device: FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)

FDBA (MinerOss®) + Mucograft® seal

EXPERIMENTAL

Interventions: Device: Mucograft® seal Procedure: Ridge preservation procedure

Device: FDBA (MinerOss®) + Mucograft® seal

Interventions

FDBA (MinerOss®) + Mucograft® seal DEVICE

Collagen matrix membrane for soft-tissue regeneration

FDBA (MinerOss®) + Mucograft® seal

FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) DEVICE

Standard of Care

FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts University: lead

Results Point of Contact

• Title: Y. Natalie Jeong
• Organization: TuftsUSDM

natalie.jeong@tufts.edu

6176366531

Study Officials

• Natalie Jeong, DMD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 3, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 31, 2020
• Results First Posted: May 16, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share