Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

NCT ID: NCT03619096

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2019-07-06

Brief Summary

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The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .

The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..

Detailed Description

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Conditions

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Gingival Recession Xenograft Model Gingival Recession, Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The participants and the outcomes Assessor are masked about the surgical technique that was performed. The surgical technique ir randomized in accordance with the arch side of each patient, so the investigator will open a envelope just before starting the incisions to know which technique will be performed.

Study Groups

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Test Group (tunnel technique)

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique

Group Type ACTIVE_COMPARATOR

tunnel technique for Root coverage with Porcine collagen Matrix

Intervention Type PROCEDURE

Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Control Group (extended flap technique)

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique

Group Type PLACEBO_COMPARATOR

extended fla technique for Root coverage with Porcine collagen Matrix

Intervention Type PROCEDURE

Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Interventions

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tunnel technique for Root coverage with Porcine collagen Matrix

Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Intervention Type PROCEDURE

extended fla technique for Root coverage with Porcine collagen Matrix

Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix

Intervention Type PROCEDURE

Other Intervention Names

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mucograft matrix mucograft matrix

Eligibility Criteria

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Inclusion Criteria

-bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

Exclusion Criteria

* diabetics
* pregnant women
* chronic use of medication
* periodontitis
* smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Arthur Belem Novaes Jr

Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Belem Novaes JR

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Marilia Bianchini Lemos Reis

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marilia B Lemos Reis

Role: CONTACT

+5516991482758

Facility Contacts

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Marilia B Lemos Reis, MSD Student

Role: primary

+5516991482758

Other Identifiers

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CAAE:65396417000005419

Identifier Type: -

Identifier Source: org_study_id

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