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N/A N=28 Randomized Single-blind Prevention

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

Tooth Extraction Status Nos

Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Changes in Alveolar Bone (mm) — -1.47; -1.21 mm

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
FDBA (MinerOss®) + Mucograft® seal (Device); FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Tufts University
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Alveolar Bone (mm)
-1.47; -1.21
SECONDARY
Changes in Hard Tissues
-0.79; -0.30
SECONDARY
Changes in Soft Tissues
0.59; 0.90
SECONDARY
Keratinized Tissue Width (mm)
-0.08; -0.08

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.

Eligibility Criteria

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

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02697890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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