"Influence of Flap Thickness Upon Root Coverage With the Use of Acellular Dermal Matrix: a Prospective Case Series"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Complete root coverage (CRC)
Study Overview
Brief Summary
OrACell has been tested as a barrier in bone regenerative procedures showing promising results in new bone formation after socket preservation, but no data is available on root coverage procedures. Moreover, it has been suggested that keratinized tissue width (KTW) ≥2mm and gingival thickness (GT) ≥1.2 mm at 6 months of the surgical procedures are two important predictors for long term stability of gingival margin Therefore, it was hypothesized that soft tissue thickness and keratinized tissue width may influence the percentage of root coverage. By means of a prospective case series (12 patients in total), the aim is to study the performance of the OrACell dermal matrix in the treatment of multiple and adjacent gingival recessions, determining the amount of complete root coverage obtained at 6 months of follow-up. At the same time, it is intended to evaluate the effect of initial gingival thickness, by means of digital scanning, upon the success of root coverage procedure with OrACell.
Detailed Description
Background:
Gingival recession is a lesion characterized by clinical attachment loss of the periodontal apparatus to the root surface of the tooth, resulting in an apical migration of the gingival margin that occasionally generates esthetic problems, hypersensitivity and difficulty in maintaining proper hygiene. To correct this, the additional use of connective tissue grafts in root coverage procedures has reported highly predictable results. Over time, different substitutes such as acellular dermal matrix (ADM), xenografts (XEN) have been suggested to reduce patient morbidity by avoiding the donor site. Recently, an acellular dermal allograft known as OrAcell® has shown good results in terms of soft tissue regeneration and guided bone/tissue regeneration.
Objectives:
Overall objective The objective of this prospective case series is to evaluate the influence of initial soft tissue thickness (STT) upon the success of a surgical root coverage procedure Specific objective To assess the statistical correlation of keratinized tissue width (KTW) and VD on the outcome (%RC) of the TUN plus acellular dermal matrix (ADM).
Hypothesis:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Periodontally and systemically healthy.
- •Presence of Cairo RT 1 and RT2 GR defects
- •Recession ≥2mm in depth at the buccal aspect.
- •Full-mouth plaque and bleeding score ≤20%.
- •No previous periodontal surgery.
- •Presence of identifiable CEJ (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).
Exclusion Criteria
- •Tobacco smoking of ≥10 cigarettes a day.
- •Contraindications for periodontal surgery.
- •Medications known to affect the gingiva or interfere with wound healing.
- •Pregnancy.
- •Active orthodontic therapy.
- •Caries or restorations in the area to be treated.
Arms & Interventions
Gingival recession treatment
Gingival recession treatment by means of tunnel technique and OrACell dermal matrix.
Intervention: Mucogingival surgery (Procedure)
Outcomes
Primary Outcomes
Complete root coverage (CRC)
Time Frame: CRC 6 months after surgery
By using the buccal surfaces of the concerned teeth as reference points for the superpositioning of the different time points (pre-operative and post-operative), this approach will allow for precise evaluation of dimensional soft tissue alterations over time by a blinded examiner
Secondary Outcomes
- : Mean Root Coverage (MRC), change in Keratinized tissue width and change in Keratinizedd tissue thickness(6 months after surgery)
Investigators
Jose Nart Molina
Chairman and Program Director, Department of Periodontology UIC-Barcelona
Universitat Internacional de Catalunya