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This study will compare two commonly used soft tissue grafting techniques (free gingival graft, FGG vs. connective tissue graft, CTG) to augment the soft tissue around dental implants with a lack of keratinized mucosa.
To investigators knowledge, these 2 types of grafts have not been compared for differences in clinical (amount of KM increase, tissue thickness increase and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
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. Soft tissue grating (with FGG or CTG) aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants in question. While FGG is typically associated with higher postoperative discomfort than CTG, it has also been considered the gold standard in the treatment of these clinical conditions.
Specific aims for this project include the evaluation of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free Gingival Graft | Active Comparator | Free Gingival Graft (FGG) |
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| Connective Tissue Graft followed by Laser Gingivoplasty | Experimental | Connective Tissue Graft (CTG) followed by Laser Gingivoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Free Gingival Graft (FGG) | Procedure | Free Gingival Graft (FGG) was performed on all study sites in this arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Increase in Keratinized Mucosa (in mm) Between the Two Grafts | Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting. | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. | From baseline to 12 months |
| Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramzi V Abou-Arraj, DDS, MS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, School of Dentistry | Birmingham | Alabama | 35294-0007 | United States |
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Randomization was performed by site in the mouth (dental implant) to receive either FGG intervention or CTG intervention. As a result, some participants received only one of the 2 interventions if they only had one qualifying site (=dental implant) while other participants received both interventions if they had multiple implants that met the inclusion criteria. Total FGG implant sites=14, total CTG sites=12.
| ID | Title | Description |
|---|---|---|
| FG000 | Free Gingival Graft | Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm. |
| FG001 | Connective Tissue Graft Followed by Laser Gingivoplasty |
| 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 | Apr 15, 2020 |
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| Connective Tissue Graft followed by Laser Gingivoplasty | Procedure | Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm. |
|
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Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. |
| From baseline to 12 months |
Connective Tissue Graft (CTG) followed by Laser Gingivoplasty
Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
| FG002 | FGG + CTG | Both FGG and CTG (at different implants in the same patient) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Free Gingival Graft | Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm. |
| BG001 | Connective Tissue Graft Followed by Laser Gingivoplasty | Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm. |
| BG002 | FGG + CTG | Both FGG and CTG (at different implants in the same patient) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| implants |
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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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | The Increase in Keratinized Mucosa (in mm) Between the Two Grafts | Compare the increase in keratinized mucosa (KM) between two commonly used soft tissue grafting techniques (FGG and CTG) by quantifying KM widths (in mm) at 12 months following soft tissue grafting. | FGG group has 2 participants who only received FGG (n=2) and 7 participants who received FGG (n=12) and CTG at different implant sites (total of 14=2+12). CTG group has 5 participants who only received CTG (n=5) and 7 participants who received FGG and CTG (n=7) at different implant sites (total of 12=5+7). | Posted | Mean | Standard Deviation | mm | From baseline to 12 months | implants | implants |
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| Secondary | Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. | FGG group has 2 participants who only received FGG (n=2) and 7 participants who received FGG (n=12) and CTG at different implant sites (total of 14=2+12). CTG group has 5 participants who only received CTG (n=5) and 7 participants who received FGG and CTG (n=7) at different implant sites (total of 12=5+7). | Posted | Mean | Standard Deviation | mm | From baseline to 12 months | implant sites | implant sites |
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| Secondary | Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. | FGG group has 2 participants who only received FGG (n=2) and 7 participants who received FGG (n=12) and CTG at different implant sites (total of 14=2+12). CTG group has 5 participants who only received CTG (n=5) and 7 participants who received FGG and CTG (n=7) at different implant sites (total of 12=5+7). | Posted | Mean | Standard Deviation | mm | From baseline to 12 months | implant sites | implant sites |
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from baseline through 12 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 | Free Gingival Graft | Free Gingival Graft (FGG) Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Connective Tissue Graft Followed by Laser Gingivoplasty | Connective Tissue Graft (CTG) followed by Laser Gingivoplasty Connective Tissue Graft followed by Laser Gingivoplasty: Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | FGG + CTG | Both FGG and CTG (at different implants in the same patient) | 0 | 7 | 0 | 7 | 0 | 7 |
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randomization was performed by site (implant) due to challenges recruiting sufficient participants for both arms
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramzi Abou-Arraj | University of Alabama at Birmingham | 2059344506 | rva@uab.edu |
| Mar 5, 2021 |
| Prot_SAP_000.pdf |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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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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| implant sites |
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| implant sites |
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