Tooth Loss
Conditions
Keywords
dental, socket grafting, bone graft, alveolar, xenograft, allograft, implant, ridge preservation, CBCT
Brief summary
To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
Detailed description
AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft. PRIMARY OBJECTIVE Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft. SECONDARY OBJECTIVE 1. Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. 2. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. 3. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site. Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT. NULL HYPOTHESIS There is no difference between the two groups for any of the parameters evaluated.
Interventions
DEVICEBone graft
Bone grafts produced by Straumann LLC
Sponsors
Institut Straumann AG
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The participant, surgeon and assessors of the CBCT will be blinded to the treatment arm. The bone graft will be chosen at random from an envelope with a list generated by Sealed Envelope Ltd
Intervention model description
Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males or females ≥ 21 years of age 2. Able to provide informed consent 3. Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections) 4. Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16) 5. Presence of natural teeth adjacent to the tooth planned for extraction 6. Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted 7. Dehiscence type defects of the sockets limited to 2/3rd length of the root
Exclusion criteria
Systemic conditions 1. Conditions and circumstances as evaluated by investigator that would prevent completion of study participation 2. Conditions requiring chronic routine use of antibiotics or steroids 3. History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections 4. Alcoholism or drug abuse and heavy smokers \>10 cigarettes a day 5. Simultaneous participation in other studies 6. Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study Local conditions 1. Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction) 2. Multi rooted teeth 3. Irradiation therapy 4. Osseous lesions 5. Missing teeth adjacent to the tooth being extracted 6. Implant restorations adjacent to the tooth being extracted 7. Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography | 6 months | Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal dimensional changes measured intra-operatively using a Periodontal Probe | 6 months | Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Measurements will be made using a periodontal probe from the Mid-buccal to the mid-palatal/mid-lingual aspect of the ridge using a surgical stent |
| Vertical dimensional changes measured intra-operatively using a periodontal probe and stent | 6 months | Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Vertical measurements will be made using a periodontal probe and a patient specific stent. The probe will help measure changes in height of buccal and palatal / lingual plate at the center of the ridge. |
| Histologic analysis of bone biopsy cores | 6 months | Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets |
Countries
United States
Outcome results
None listed