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| Name | Class |
|---|---|
| Dentsply Sirona Implants and Consumables | INDUSTRY |
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The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum graft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic at 1 year after implant placement for implant evaluation. At this final study appointment, x-rays and a 3D intraoral scan will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be assessed via bleeding upon probing and completion of a brief questionnaire, respectively.
An alveolar ridge is the part of the jawbone which immediately surrounds and anchors the tooth socket ("alveolus"). Similar to any bone or muscle atrophying when not used, the alveolar ridge will shrink ("resorb") following tooth extraction. The volume of an alveolar ridge can be measured by both 3 Dimensional ("3D") intraoral scan and radiography, and is used clinically as a metric of oral health.
A dental implant is a medical-grade titanium screw placed into healed alveolar bone or a tooth socket following tooth extraction. It replaces the tooth root and supports the crown, or "dental cap"; an artificial tooth generally made with porcelain or surgical grade metals.
Implant success requires both sufficient bone alveolar volume and sufficient mucosal tissue to protect against biofilm-mediated inflammation, assure functional comfort and contribute to dental implant esthetics. Following dental implant placement, the alveolar ridge resorbs approximately 0.5 to 1.0 mm during the first year. Healed ridges are also often volumetrically deficient, losing up to 30% of their horizontal volume following tooth extraction.
To remedy this, peri-implant mucosal grafting has been proposed and is currently part of dental implant therapy. Both autogenous grafts (mucosal connective tissue from the roof of the patient's own mouth or "palate") and allogeneic grafts (collagen-rich grafts derived from a genetically non-identical human donor) are used for these purposes, but there is controversy regarding the effectiveness of supplemental graft use during implant treatment.
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum allograft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic about 1 year after implant placement for assessment of the implant evaluation. At this final study appointment, x-rays, a 3D intraoral scan and intraoral photographs of the implant will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be measured via bleeding upon probing and completion of a brief questionnaire, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant with prophylactic allograft | Experimental | Implant placement will be performed with simultaneous placement of the allograft. |
|
| Implant without prophylactic allograft | Active Comparator | Implant placement will be performed without a graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allograft mucosal enhancement with dental implant | Device | implant placement with allograft mucosal enhancement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning | Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning | 12 months post implant surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Implant Survival | Implant survival at 12 months post implant surgery. Percentage of implants surviving after 12 months of placement | 12 months post implant surgery |
| Marginal Bone Levels (MBLs) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient satisfaction with implant therapy as measured by the Oral Health Impact Profile | 12 months post implant surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Al-Tarawneh | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago College of Dentistry | Chicago | Illinois | 60611 | United States |
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The target was to recruit a total of 40 participants (20 for each group) and up to 60 as a maximum. The number that was eventually enrolled in the study was 39.
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant With Prophylactic Allograft | Allograft mucosal enhancement with dental implant: implant placement with allograft mucosal enhancement |
| FG001 | Implant Without Prophylactic Allograft | No allograft mucosal enhancement at time of dental implant placement: implant placement without allograft mucosal enhancement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Implant With Prophylactic Allograft | Allograft mucosal enhancement with dental implant: implant placement with allograft mucosal enhancement |
| BG001 | Implant Without Prophylactic Allograft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning | Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning | Posted | Mean | Standard Deviation | percentage of volume change | 12 months post implant surgery |
|
Throughout the study from the time of enrollment until study closure which is marked by the one year follow up of the all participants who came back to that visit.
All adverse events were monitored throughout the study period. The nature of standard routine implant placement procedure doesn't impose serious risk, and none of the participants experienced any adverse side effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Implant With Prophylactic Allograft | Implant placement will be performed with simultaneous placement of the allograft. Allograft mucosal enhancement with dental implant: implant placement with allograft mucosal enhancement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lyndon Cooper, Dean | Virginia Commonwealth University | (804) 828-7235 | cooperlf@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2019 | Dec 4, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015921 | Dental Implants |
| ID | Term |
|---|---|
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
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subjects will be randomized to one of two groups
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| No allograft mucosal enhancement at time of dental implant placement | Device | implant placement without allograft mucosal enhancement |
|
Marginal bone levels (in millimeters) as measured by radiographic translucency. Bone levels between implant/abutment interface and crest of the bone were measured at time of implant placement and at 12 months later. The negative sign in the results below indicates that there was bone loss in both groups.
| 12 months post implant surgery |
| Vertical Tissue Change as Measured by 3D Intraoral Scanning | This measurement is for the vertical position of the gingival margin change based on superimposed 3D intraoral scans | 12 months post surgery |
No allograft mucosal enhancement at time of dental implant placement: implant placement without allograft mucosal enhancement
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Implant Survival | Implant survival at 12 months post implant surgery. Percentage of implants surviving after 12 months of placement | Two implants in the group (Implant without prophylactic allograft failed resulting in a 90% survival rate in that group and 95% overall survival rate for the study. | Posted | Number | Percentage | 12 months post implant surgery |
|
|
|
| Secondary | Marginal Bone Levels (MBLs) | Marginal bone levels (in millimeters) as measured by radiographic translucency. Bone levels between implant/abutment interface and crest of the bone were measured at time of implant placement and at 12 months later. The negative sign in the results below indicates that there was bone loss in both groups. | Posted | Mean | Standard Deviation | mm | 12 months post implant surgery |
|
|
|
| Secondary | Vertical Tissue Change as Measured by 3D Intraoral Scanning | This measurement is for the vertical position of the gingival margin change based on superimposed 3D intraoral scans | Posted | Mean | Standard Deviation | mm | 12 months post surgery |
|
|
|
| Other Pre-specified | Patient Satisfaction | Patient satisfaction with implant therapy as measured by the Oral Health Impact Profile | Not Posted | 12 months post implant surgery | Participants |
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Implant Without Prophylactic Allograft | Implant placement will be performed without a graft No allograft mucosal enhancement at time of dental implant placement: implant placement without allograft mucosal enhancement | 0 | 20 | 0 | 20 | 0 | 20 |
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| D003813 |
| Dentistry |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |