NCT03095378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

March 23, 2017

Last Update Submit

March 23, 2017

Conditions

Gingival Recession

Keywords

gingival recession

Outcome Measures

Primary Outcomes (1)

  • Total root coverage measured with a periodontal probe in mm

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

    one year

Secondary Outcomes (2)

  • Keratinized mucosa width measured with a periodontal probe in mm

    one year

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

    one year

Study Arms (3)

Control

ACTIVE COMPARATOR

Root treatment with scaling and root planing.

Procedure: Control

Citric acid plus tetracycline

EXPERIMENTAL

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

Procedure: citric acid plus tetracycline

Antimicrobial photodynamic therapy

EXPERIMENTAL

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)

Procedure: antimicrobial photodynamic therapy

Interventions

ControlPROCEDURE

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

Control
citric acid plus tetracyclinePROCEDURE

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

Citric acid plus tetracycline
antimicrobial photodynamic therapyPROCEDURE

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

Antimicrobial photodynamic therapy

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 26358636BACKGROUND

  • 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.

    PMID: 26095265BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Citric AcidTetracycline

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

CitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor did not have access to patient's records
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventions in different patients
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 29, 2017

Study Start

March 10, 2014

Primary Completion

February 10, 2017

Study Completion

March 10, 2017

Last Updated

March 29, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)