Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials

University of North Carolina (UNC)

Status: Terminated

Conditions: Tooth Injuries; Tooth Fractures; Tooth Diseases

Treatments: Biological: Membrane; Biological: Xenograft, Membrane; Biological: Allograft, Membrane; Biological: Alloplast, Membrane

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02532543

15-1114

Details and patient eligibility

About

This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of informed consent
2. ≥ 18 years and ≤ 75 years
3. Good physical health (ASAI/II)
4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
5. Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies

Exclusion criteria

1. Buccal plate dehiscence and/or fenestration >3mm at study site following extraction

2. Untreated rampant caries and uncontrolled periodontal disease

3. Inadequate oral hygiene (estimated plaque score >20%)

4. Smokers using more than 10 cigarettes or equivalent per day

5. Smokeless tobacco use or e-cigarette use

6. Compromised physical health and/or uncontrolled or severe systemic diseases including:

   ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse

7. Systemic or local disease or condition that would compromise post-operative healing

8. Use of any substance or medication that will influence bone metabolism

9. Known pregnancy

10. Unable or unwilling to return for follow-up visits for a period of 6 months

11. Unlikely to be able to comply with study procedures according to Investigators judgement

12. Involvement in the planning and conduct of the study

13. Previous enrollment or randomization of treatment in the present study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Group A- Allograft, Membrane

Active Comparator group

Description:

Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane

Treatment:

Biological: Allograft, Membrane

Group B- Alloplast, Membrane

Active Comparator group

Description:

Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane

Treatment:

Biological: Alloplast, Membrane

Group C- Xenograft, Membrane

Active Comparator group

Description:

OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane

Treatment:

Biological: Xenograft, Membrane

Group D- Membrane

Active Comparator group

Description:

Symbios OsteoShield Collagen Resorbable Membrane

Treatment:

Biological: Membrane