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. The SAMRI technique described is a novel technique involving a simplified incision and suturing technique and to the investigators' knowledge, this is the first study that seeks to compare this technique to other techniques for differences in clinical outcomes (percentage root coverage, resultant tissue thickness, and width of keratinized tissue) and patient-centered outcomes (post-operative pain, swelling, changes in daily activities, and patient-assessed esthetics) in a controlled study.
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 suggest that decreased intrasurgical time and the simplified protocol of the SAMRI technique may result in improved clinical outcomes and/or a decrease in postoperative morbidity and complications as assessed by patients. Specific aims for this project include the evaluation of: * Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM * KT width at 6 and 12 month following grafting with SAMRI 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Side Access Mucosal Releasing Incision (SAMRI) 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
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
Percentage of root coverage at 6 and 12 months following grafting with SAMRI and sulcular tunnel access with ADM
Compare the change in the exposed root surface at sites with gingival recession.
Time frame: From baseline to 6 months and 12 months
KT width at 6 and 12 month following grafting with SAMRI and sulcular tunnel access with ADM
Compare the change in keratinized tissue (KT) between two incision designs for root coverage and tissue augmentation.
Time frame: From baseline to 6 and 12 months
Change in tissue thickness of the grafted sites at 6 and 12 months
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 6 and 12 months
Assessed esthetic outcomes using a standardized pink esthetic scale (PES) at 6 and 12 months postoperatively
Assess esthetic outcomes using an established periodontal esthetic score (PES). This score evaluates the color of the gum utilizing 5 subscales ranging from 0(worse) to 2 (better) allowing for a summed total score of 10.
Time frame: From baseline to 6 and 12 months
Assessed esthetic outcomes at 6 and 12 months post-operatively
A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities will be administered. This measurement ranges from 0-10 (0 being better and 10 being worse).
Time frame: At 6 and 12 months postoperatively
Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 1 week and 1 month postoperatively
A visual analogue scale (VAS) based questionnaire regarding esthetic appearance, pain, swelling, bruising, effects on daily activities. This measurement ranges from 0-10 (0 being better and 10 being worse).
Time frame: 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months postoperatively.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.