Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Gingival Recession
  • Lack of Keratinized Gingiva
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

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 ...

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

Tracking Information

NCT #
NCT04179448
Collaborators
Not Provided
Investigators
Principal Investigator: Maria Geisinger, DDS, MS University of Alabama at Birmingham