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Flap Thickness Upon Root Coverage With the Use of Acellular Dermal Matrix

NCT04802473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-04

No results posted yet for this study

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.

Conditions

  • Gingival Recession
  • Periodontal Attachment Loss
  • Periodontal Diseases
  • Soft Tissue Injuries

Interventions

PROCEDURE

Mucogingival surgery

In brief description, Tunnel+acellular dermal matrix treatment will be performed by starting initial sulcular incisions, tunneling knives will be used to elevate the buccal gingiva by means of a full-thickness flap elevation. Flap preparation will be extended beyond the MGJ. The exposed root surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. ADM (OrACELL, LifeNet Helth, Virginia Beach, VA, USA) of 1.25-1.75mm in thickness will be cut to the exact size of the defect, and will be inserted into the tunnel, and subsequently covered advancing the flap by means of sling sutures to stabilize the flap in a coronal position (6-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA). Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Jose Nart, PhD · UIC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2022-04-15
Completion
2022-04-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802473 on ClinicalTrials.gov