To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 11/4/2018 |
| Start Date: | January 7, 2016 |
| End Date: | October 9, 2020 |
A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
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.
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:
- 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
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
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)
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