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Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Control

citric acid plus tetracycline

antimicrobial photodynamic therapy

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth
Indication of root coverage by dentin hypersensitivity or esthetic

Exclusion Criteria:

Smokers
Pregnancy
Systemic medication use that could impair wound healing or surgery procedure
Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

Sites / Locations

Bauru School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Control

Citric acid plus tetracycline

Antimicrobial photodynamic therapy

Arm Description

Root treatment with scaling and root planing.

Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s.

Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s)

Outcomes

Primary Outcome Measures

Total root coverage measured with a periodontal probe in mm

Distance from cemento-enamel junction to gingival margin = 0 mm

Secondary Outcome Measures

Keratinized mucosa width measured with a periodontal probe in mm

Ideal if keratinized mucosa width > 5mm

Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale

Ideal if scale = 0

Full Information

NCT ID

NCT03095378

First Posted

March 23, 2017

Last Updated

March 23, 2017

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03095378

Brief Title

Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

Official Title

Evaluation of Root Coverage by Subepithelial Connective Graft Associated to Root Conditioning by Citric Acid Plus Tetracycline and Antimicrobial Photodynamic Therapy: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

March 10, 2014 (Actual)

Primary Completion Date

February 10, 2017 (Actual)

Study Completion Date

March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study was to evaluate the effect of two root-conditioning agents used in conjunction with subepithelial connective graft technique on root coverage outcomes. One is citric acid plus tetracycline and the other is antimicrobial photodynamic therapy.

Detailed Description

Citric acid plus tetracycline has properties of root surface decontamination, surface demineralization and exposure of collagen fibers. Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

gingival recession

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Interventions in different patients

Masking

Outcomes Assessor

Masking Description

The outcome assessor did not have access to patient's records

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Root treatment with scaling and root planing.

Arm Title

Citric acid plus tetracycline

Arm Type

Experimental

Arm Description

Root treatment with 50% citric acid plus 10% tetracycline, pH1, passive application for 90s.

Arm Title

Antimicrobial photodynamic therapy

Arm Type

Experimental

Arm Description

Antimicrobial photodynamic therapy with toluidine blue O (100ug/ml - 60s pre-irradiation - pH4) and red laser (660nm, 30 milliwatts, 45 joules per square centimeter, sweeping mode, 90s)

Intervention Type

Procedure

Intervention Name(s)

Control

Intervention Description

Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing

Intervention Type

Procedure

Intervention Name(s)

citric acid plus tetracycline

Intervention Description

Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline

Intervention Type

Procedure

Intervention Name(s)

antimicrobial photodynamic therapy

Intervention Description

Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy

Primary Outcome Measure Information:

Title

Total root coverage measured with a periodontal probe in mm

Description

Distance from cemento-enamel junction to gingival margin = 0 mm

Time Frame

one year

Secondary Outcome Measure Information:

Title

Keratinized mucosa width measured with a periodontal probe in mm

Description

Ideal if keratinized mucosa width > 5mm

Time Frame

one year

Title

Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale

Description

Ideal if scale = 0

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gingival recession - Miller's class I or II (2 to 5 mm of height) at least in one tooth Indication of root coverage by dentin hypersensitivity or esthetic Exclusion Criteria: Smokers Pregnancy Systemic medication use that could impair wound healing or surgery procedure Systemic diseases as diabetes, uncontrolled hypertension, coagulation diseases, kidney diseases.

Facility Information:

Facility Name

Bauru School of Dentistry

City

Bauru

State/Province

Sao Paulo

ZIP/Postal Code

17012-901

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26358636

Citation

Damante CA, Ducati P, Ferreira R, Salmeron S, Zangrando MSR, de Rezende MLR, Sant'Ana ACP, Greghi SLA, Magalhaes AC. In vitro evaluation of adhesion/proliferation of human gingival fibroblasts on demineralized root surfaces by toluidine blue O in antimicrobial photodynamic therapy. Photodiagnosis Photodyn Ther. 2016 Mar;13:303-307. doi: 10.1016/j.pdpdt.2015.08.009. Epub 2015 Sep 7.

Results Reference

background

PubMed Identifier

26095265

Citation

Karam PS, Sant'Ana AC, de Rezende ML, Greghi SL, Damante CA, Zangrando MS. Root surface modifiers and subepithelial connective tissue graft for treatment of gingival recessions: a systematic review. J Periodontal Res. 2016 Apr;51(2):175-85. doi: 10.1111/jre.12296. Epub 2015 Jun 11.

Results Reference

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Evaluation of Root Coverage by Connective Graft and Different Root Conditioning Methods

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