Print

Purpose

This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 teeth (up to four) with Miller class I or II gingival recession defects and less than or equal to 2mm of KT at each site to be treated. - Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s) - No anticipated need for restorative care at the teeth to be treated during the study period.

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 active periodontal disease or radiographic interproximal bone loss or tooth malposition, which would yield a Miller class III or IV categorization for the recession defect. - Presence of frenulae or other soft tissue anomalies at the site(s) to be treated that, in the opinion of the investigators, will interfere with successful access and treatment of the soft tissue defects. - Previous soft tissue grafting at the site(s) to be treated

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VISTA 		VISTA incision with CAF and ADM
  • Procedure: VISTA
    Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
Active Comparator
Sulcular Tunnell access 		Sulcular tunnel surgery with CAF and ADM
  • Procedure: STA
    Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix

More Details

Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Detailed Description

Research data and daily clinical observations reveal that teeth with gingival recession and a lack of adequate keratinized tissue (KT) are more prone to persistent gingival inflammation, dentinal sensitivity, radicular (root) caries (tooth decay), faster periodontal attachment loss, and compromised plaque control. Soft tissue grating (by various techniques) aims at changing the quality, quantity and placement of the soft tissue around teeth by covering exposed root surfaces and creating or increasing the zone of keratinized mucosa (KM) surrounding the affected teeth. Both techniques tested have shown good clinical outcomes with regard to root coverage, but clinical reports of the VISTA technique and other similar techniques suggest that patients experience a decrease in site morbidity and discomfort post-operatively. This study will compare two surgical incision designs used in conjunction with coronally advanced flap (CAF) and acellular dermal matrix (ADM) Specific aims for this project include the evaluation of: - Percentage of root coverage at 6 and 12 months following grafting with VISTA and sulcular tunnel access with ADM - KT width at 6 and 12 month following grafting with VISTA and sulcular tunnel access with ADM - Change in tissue thickness of the grafted sites at 6 and 12 months - Practitioner-assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively - Patient-assessed esthetic outcomes at 6 and 12 months post-operatively - Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.