Clinical Comparison Between Two Surgical Techniques for t... | NCT01175720

Studies
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions

NCT01175720

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Nov 16, 2011Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Gingival Recession

Interventions

Periodontal surgery to gingival recessions

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Aug 3, 2010

First Submission Date that Met QC Criteria

Aug 4, 2010

First Posted Date

Aug 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2011

Last Update Posted Date

Nov 16, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arthur Belem Novaes Jr, Clinical comparison between two surgical techniques with acellular dermal matrix graft in the treatment of gingival recessions, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
test and control	Experimental	The test and control technique will be tested in a split-mouth design.	Procedure: Periodontal surgery to gingival recessions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Periodontal surgery to gingival recessions	Procedure	Test and control technique to treat gingival recessions.	test and control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of root coverage	Clinical parameters will be assessed after 6 months of surgical procedures.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Keratinized Tissue	Clinical parameters will be assessed after 6 months of surgical procedures.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
Main complaint aesthetic issues or dentine hypersensitivity
The patient must be a candidate for bilateral root coverage procedure
Patient shows sufficient plaque control (FMPS < 20%)
The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

Smokers
Systemic diseases
Pregnants or lactating
Periodontal disease
General contraindications for dental and/or surgical treatment are present
The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arthur B. Novaes Júnior, PhD	University of Sao Paulo	Principal Investigator
Lauro G. Ayub, MSD student	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry of Ribeirão Preto USP		Ribeirão Preto	São Paulo	14040-904	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22712624	Derived	Ayub LG, Ramos UD, Reino DM, Grisi MF, Taba M Jr, Souza SL, Palioto DB, Novaes AB Jr. A Randomized comparative clinical study of two surgical procedures to improve root coverage with the acellular dermal matrix graft. J Clin Periodontol. 2012 Sep;39(9):871-8. doi: 10.1111/j.1600-051X.2012.01915.x. Epub 2012 Jun 19.

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases