Tooth Loss
Conditions
Brief summary
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
Detailed description
Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients. The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.
Interventions
DEVICEallograft + x-link collagen membrane
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
DEVICExenograft + non-x-link collagen
Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
Sponsors
Geistlich Pharma AG
McGuire Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects 18 to 70-yrs of age 2. Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing) 3. Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket 4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF). 5. Subjects must be able and willing to follow study procedures and instructions.
Exclusion criteria
1. Subjects with a history of any tobacco use within the last six months. 2. Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. 3. Subjects taking intramuscular or intravenous bisphosphonates. 4. Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic. 5. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration 6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental). 7. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months | Six Months | The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Bone Plus Graft Content at 6-months | Six Months | New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area. |
| Wound Closure at 4-weeks | 4-weeks | Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited at all 9 investigation sites between October 2013 and June 2014.
Participants by arm
| Arm | Count |
|---|---|
| Allograft + X-link Collagen Membrane Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0. | 21 |
| Xenograft + Non-x-link Collagen Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.
Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0. | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Allograft + X-link Collagen Membrane | Xenograft + Non-x-link Collagen | Total |
|---|---|---|---|
| Age, Continuous | 55.9 years STANDARD_DEVIATION 10.7 | 55.3 years STANDARD_DEVIATION 13.3 | 55.7 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
Time frame: Six Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allograft + X-link Collagen Membrane | Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months | Bone Ridge Buccal-Lingual Width | 4.95 mm | Standard Deviation 2.65 |
| Allograft + X-link Collagen Membrane | Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months | Bone Ridge Apico-Coronal Height | 5.29 mm | Standard Deviation 3.73 |
| Xenograft + Non-x-link Collagen | Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months | Bone Ridge Buccal-Lingual Width | 6.71 mm | Standard Deviation 2.07 |
| Xenograft + Non-x-link Collagen | Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months | Bone Ridge Apico-Coronal Height | 6.24 mm | Standard Deviation 2.98 |
Secondary
New Bone Plus Graft Content at 6-months
New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area.
Time frame: Six Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Allograft + X-link Collagen Membrane | New Bone Plus Graft Content at 6-months | 46.14 percentage of total area | Standard Deviation 7.66 |
| Xenograft + Non-x-link Collagen | New Bone Plus Graft Content at 6-months | 49.21 percentage of total area | Standard Deviation 8.27 |
Secondary
Wound Closure at 4-weeks
Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.
Time frame: 4-weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Allograft + X-link Collagen Membrane | Wound Closure at 4-weeks | 2.26 mm | Standard Deviation 2.68 |
| Xenograft + Non-x-link Collagen | Wound Closure at 4-weeks | 0.79 mm | Standard Deviation 1.55 |