Adjunctive Benefit of a Xenogenic Collagen Matrix

NCT03833765 | Completed

• 1 other identifier: STXen
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap with respect to a coronal advanced flap alone in the treatment of multiple gingival recession defects in adult population.

Conditions

Gingival Recession

Keywords

gingival recession

Outcome Measures

Primary Outcomes (1)

• Mean Recession Reduction

  The distance between CEJ and the free gingival margin (Rec depth) will be measured at baseline, 3, 6 and 12 months. The mean change will be then calculated.

  12 months

Study Arms (2)

CAF+XCM

EXPERIMENTAL

An envelope split-full-split thickness flap without vertical incisions will be carried out in the gingival recession area. Afterwards, a xenogenic collagen matrix (XCM) will be applied to all teeth with recession defect. The XCM will be cut into the right dimensions, measured with the probe, and its measurements recorded; then it will be placed from the CEJ to the bone crest on the recipient bed using single sutures, 7/0 PGA sutures. The matrix will be rehydrated with blood, in order to reconstitute and maintain the maximal thickness possible. The flap will be closed slightly coronal to the CEJ with a sling suture using resorbable PGA 6/0 sutures and avoiding any compression of the matrix.

Procedure: CAF+XCM

CAF alone

ACTIVE COMPARATOR

An envelope split-full-split thickness flap without vertical incisions will be carried out. The root surfaces will be mechanically treated with the use of curettes. A sharp dissection into the vestibular lining mucosa will be then carried out to eliminate muscle tension. Sling sutures will be performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the de-epithelialized anatomic papillae.

Procedure: CAF alone

Interventions

CAF+XCM PROCEDURE

After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap.

CAF+XCM

CAF alone PROCEDURE

Coronally Advanced Flap procedure alone was performed to treat multiple recession defects

CAF alone

Eligibility Criteria

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

You may qualify if:

• The patient (male or female) must be 18 years or older
• Presence of gingival recessions in the upper jaw, involving teeth from central incisor to first molar
• Gingival recessions on at least 2 adjacent teeth with a minimal depth of 2mm and detectable cemento-enamel junction (CEJ) (abrasion step \<1mm)
• The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
• Full Mouth Plaque (FMPS) and Bleeding (FMBS) Score \<20%
• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

You may not qualify if:

• Smoker patients
• Pregnant patients
• Patients affect by uncontrolled diabetes
• General contraindications for dental and/or surgical treatment are present
• History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
• The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs, anticoagulation drugs)
• The patient has a disease, which affects connective tissue metabolism (e.g. collagenases)
• The patient is allergic to collagen
• The patient is an abuser of alcohol or drug
• Patients have participated in a clinical trial within the last six months
• Presence of untreated periodontitis
• Gingival recessions on molar teeth (excluding the first) or on malpositioned teeth
• Presence of abrasion ≥ 1 mm or cervical restoration, with non-detectable CEJ

Sponsors & Collaborators

• Roberto Rotundo: lead
• Geistlich Pharma AG: collaborator

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design according to CONSORT statement

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: November 28, 2012
• Primary Completion: May 3, 2016
• Study Completion: July 17, 2017
• Last Updated: February 12, 2019

Record last verified: 2019-02