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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT03619096

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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..

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession Xenograft Model Gingival Recession, Generalized	Procedure: tunnel technique for Root coverage with Porcine collagen Matrix Procedure: extended fla technique for Root coverage with Porcine collagen Matrix	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

Actual Study Start Date :

Mar 6, 2017

Actual Primary Completion Date :

Jun 6, 2018

Anticipated Study Completion Date :

Jul 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test Group (tunnel technique) It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique	Procedure: tunnel technique for Root coverage with Porcine collagen Matrix Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix Other Names: mucograft matrix
Placebo Comparator: Control Group (extended flap technique) It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique	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 Other Names: mucograft matrix

Arm

Intervention/Treatment

Active Comparator: Test Group (tunnel technique)

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

Procedure: tunnel technique for Root coverage with Porcine collagen Matrix

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

Other Names:

mucograft matrix

Placebo Comparator: Control Group (extended flap technique)

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

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

Other Names:

mucograft matrix

Outcome Measures

Primary Outcome Measures

Root coverage (milimeters) [baseline, 6 and 12 motnhs]
Root Coverage is measured by the difference between Gingival Recession Hight at baseline and 12 months

Secondary Outcome Measures

Keratinized tissue (milimeters) [baseline, 6 and 12 months]
Keratinized tissue is measured by its width and thickness.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marilia Bianchini Lemos Reis	Ribeirão Preto	São Paulo	Brazil

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator: Arthur Belem Novaes JR, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arthur Belem Novaes Jr, Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT03619096

Other Study ID Numbers:

CAAE:65396417000005419

First Posted:

Aug 7, 2018

Last Update Posted:

Aug 7, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Arthur Belem Novaes Jr, Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics, University of Sao Paulo

Gingival recession

porcine collagen matrix

multiple gingival recessions

tunnel technique

Additional relevant MeSH terms:

Gingival Recession

Study Results

No Results Posted as of Aug 7, 2018