Clinical trial NCT03338686: To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
Official title: A Prospective Randomized Clinical Trial to Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Alveolar Mucosa
Keywords: Keratinized tissue
Keratinized mucosa
Attached mucosa
Dental implants
Free gingival graft
Connective tissue graft
Patient-centered outcomes
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: The Increase in Keratinized Mucosa (in mm) Between the Two Grafts
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG
timeFrame: From baseline to 12 months
measure: Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ramzi V Abou-Arraj, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: