Dental Implants, Alveolar Mucosa
Conditions
Keywords
Keratinized tissue, Keratinized mucosa, Attached mucosa, Dental implants, Free gingival graft, Connective tissue graft, Patient-centered outcomes
Brief summary
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.
Detailed description
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: * KM width at 6 and 12 months following grafting with FGG and CTG * Change in tissue thickness of the grafted sites at 6 and 12 months * Esthetic outcomes using a newly developed peri-implant esthetic scale at 6 and 12 month * Patient centered outcomes including pain, bleeding, swelling and change in daily activities at 1 week for both groups and at 1 month for the CTG group
Interventions
PROCEDUREFree Gingival Graft (FGG)
Free Gingival Graft (FGG) was performed on all study sites in this arm.
PROCEDUREConnective Tissue Graft followed by Laser Gingivoplasty
Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
1. English speaking 2. At least 18 years old 3. Must be a patient of the UAB Dental School, able to read and understand informed consent document 4. One or more adjacent dental implants having \<2mm in width of keratinized mucosa or attached mucosa \<1mm around their buccal aspect Contra-lateral or opposing implant sites with above criteria may be included and randomly assigned to soft tissue graft type 5. No crestal bone loss or minimal bone resorption not extending apical to first implant thread 6. Presence of periodontally healthy neighboring teeth, healthy implants or edentulous ridge on either side of the involved site (s) 7. Implants requiring soft tissue grafting after placement (\>2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration
Exclusion criteria
1. Non-English speaking 2. Less than 18 years old 3. Smokers/tobacco users (\>10 cigarettes/day) 4. Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing 5. Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s) 6. Presence of soft tissue recession exposing threads at implant site 7. Presence of bony dehiscence at implant site (s)\_ at time of surgery 8. Previous soft tissue grafting at the implant site (s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Increase in Keratinized Mucosa (in mm) Between the Two Grafts | From baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG | From baseline to 12 months | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. |
| Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG | From baseline to 12 months | Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between FGG and CTG following soft tissue grafting. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Free Gingival Graft Free Gingival Graft (FGG)
Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm. | 2 |
| Free Gingival Graft Free Gingival Graft (FGG)
Free Gingival Graft (FGG): Free Gingival Graft (FGG) was performed on all study sites in this arm. | 2 |
| 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. | 5 |
| 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. | 5 |
| FGG + CTG Both FGG and CTG (at different implants in the same patient) | 7 |
| FGG + CTG Both FGG and CTG (at different implants in the same patient) | 19 |
| Total | 40 |
Baseline characteristics
| Characteristic | Free Gingival Graft | Connective Tissue Graft Followed by Laser Gingivoplasty | FGG + CTG | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 | 0 / 7 |
| other Total, other adverse events | 0 / 2 | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 | 0 / 7 |
Outcome results
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.
Time frame: From baseline to 12 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free Gingival Graft | The Increase in Keratinized Mucosa (in mm) Between the Two Grafts | 3.29 mm | Standard Deviation 1.88 |
| Connective Tissue Graft Followed by Laser Gingivoplasty | The Increase in Keratinized Mucosa (in mm) Between the Two Grafts | 1.29 mm | Standard Deviation 1.05 |
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.
Time frame: From baseline to 12 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free Gingival Graft | Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG | 0.21 mm | Standard Deviation 0.98 |
| Connective Tissue Graft Followed by Laser Gingivoplasty | Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG | 0.38 mm | Standard Deviation 0.8 |
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.
Time frame: From baseline to 12 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Free Gingival Graft | Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG | 0.21 mm | Standard Deviation 0.75 |
| Connective Tissue Graft Followed by Laser Gingivoplasty | Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG | 0.79 mm | Standard Deviation 0.58 |