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This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.
Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.
Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.
Specific aims for this project include the evaluation of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| connective tissue graft | Experimental | Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
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| Acellular Dermal Matrix | Experimental | Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
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| No soft tissue graft (Control) | Active Comparator | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Connective tissue graft at time of bone graft | Procedure | following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe. | From baseline to 6 months |
| Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. | From baseline to 6 months |
| Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe. | From baseline to 6 months |
| Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. | From baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hussein Basma, DDS, MS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unversity of Alabama at Birmingham, School of Dentistry | Birmingham | Alabama | 35294-0007 | United States |
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Patients in the School of Dentistry Periodontology Clinic in need of grafting treatment will be told about the study and if interested in participation will be scheduled for a screening visit for study entry by periodontal residents and faculty members.
Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12.
| ID | Title | Description |
|---|---|---|
| FG000 | Connective Tissue Graft | Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Connective tissue graft at time of bone graft: following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 3, 2023 |
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| Acellular Demal Matrix at time of bone graft | Procedure | following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
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| No soft tissue grafting at time of bone graft | Procedure | Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
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| FG001 | Acellular Dermal Matrix | Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Acellular Demal Matrix at time of bone graft: following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| FG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Connective Tissue Graft | Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Connective tissue graft at time of bone graft: following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| BG001 | Acellular Dermal Matrix | Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Acellular Demal Matrix at time of bone graft: following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft |
| BG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Measure Changes Clinically in Crestal Soft Tissue Thickness (in mm) | The changes in clinical vertical crestal soft tissue thickness by using an endodontic file and periodontal probe. | Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12. | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | dental implant site | dental implant site |
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| Primary | Measure Changes Digitally in Crestal Soft Tissue Thickness (in mm) | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. | Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12. | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | dental implant site | dental implant site |
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| Primary | Measure Changes Clinically in Soft Tissue Thickness at 4mm Apical From Gingival Margin | The changes in clinical soft tissue thickness at 4mm apical form the gingival margin by using an endodontic file and periodontal probe. | Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12. | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | dental implant site | dental implant site |
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| Primary | Measure Changes Digitally in Soft Tissue Thickness at 4mm Apical Form Gingival Margin | The changes in soft tissue thickness digitally with superimposition of the intraoral scan and cone-bone computed tomography scan. | Randomization was performed by site in the mouth (dental implant site) to receive either CTG intervention, ADM or control. Total CTG sites=13, total ADM sites=16 and control sites=12. | Posted | Mean | Standard Deviation | mm | From baseline to 6 months | dental implant site | dental implant site |
|
Baseline to 6 months
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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 | Connective Tissue Graft | Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Connective tissue graft at time of bone graft: following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Acellular Dermal Matrix | Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft Acellular Demal Matrix at time of bone graft: following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. | 0 | 8 | 0 | 8 | 0 | 8 |
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Randomization was performed by site (dental implant) due to challenges recruiting sufficient participants for all arms.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hussein Basma, DDS, MS | University of Alabama at Birmingham | 2059344506 | basma86@uab.edu |
| Nov 2, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
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| OG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
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| OG002 | No Soft Tissue Graft (Control) | Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. No soft tissue grafting at time of bone graft: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added. |
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