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

NCT04802473 | Completed DMC

• 1 other identifier: PER-ECL-2019-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Complete root coverage (CRC)

  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

  CRC 6 months after surgery

Secondary Outcomes (1)

• : Mean Root Coverage (MRC), change in Keratinized tissue width and change in Keratinizedd tissue thickness

  6 months after surgery

Study Arms (1)

Gingival recession treatment

EXPERIMENTAL

Gingival recession treatment by means of tunnel technique and OrACell dermal matrix.

Procedure: Mucogingival surgery

Interventions

Mucogingival surgery PROCEDURE

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.

Also known as: Treatment of adjacent multiple gingival recessions using the OrACell® dermal matrix

Gingival recession treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Gonzalo Blasi

Barcelona, 08034, Spain

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Wounds and Injuries

Study Officials

• Jose Nart, PhD

  UIC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Program Director, Department of Periodontology UIC-Barcelona

Model Details: A prospective case series with a 6-month follow-up.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: July 9, 2020
• Primary Completion: April 15, 2022
• Study Completion: April 22, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)