N/A N=14 Randomized Treatment

To Compare Free Gingival Grafts and Connective Tissue Grafts Around Implants With Lack of Keratinized Mucosa

Dental Implants · Alveolar Mucosa

Bottom Line

View on ClinicalTrials.gov: NCT03338686 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: The Increase in Keratinized Mucosa (in mm) Between the Two Grafts — 3.29; 1.29 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Free Gingival Graft (FGG) (Procedure); Connective Tissue Graft followed by Laser Gingivoplasty (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY The Increase in Keratinized Mucosa (in mm) Between the Two Grafts	3.29; 1.29	—
SECONDARY Measure Changes in Tissue Thickness at 2mm From GM (in mm) Between FGG and CTG	0.21; 0.38	—
SECONDARY Measure Changes in Tissue Thickness at 5mm From GM (in mm) Between FGG and CTG	0.21; 0.79	—

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.

Eligibility Criteria

Inclusion Criteria

English speaking
At least 18 years old
Must be a patient of the UAB Dental School, able to read and understand informed consent document
One or more adjacent dental implants having 2 months): implants with healing abutments awaiting restoration or after delivery of temporary/permanent restoration

Exclusion Criteria

Non-English speaking
Less than 18 years old
Smokers/tobacco users (>10 cigarettes/day)
Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
Presence of peri-implantitis, acute infection and/or suppuration at the implant placement site (s)
Presence of soft tissue recession exposing threads at implant site
Presence of bony dehiscence at implant site (s)\_ at time of surgery
Previous soft tissue grafting at the implant site (s)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03338686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.