NCT02118155

Brief Summary

The purpose of this study was to evaluate the 6-month outcomes of applying low-intensity laser therapy associated with connective tissue grafts to treat gingival recession.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

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

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 21, 2014

Status Verified

April 1, 2014

Enrollment Period

2.2 years

First QC Date

April 16, 2014

Last Update Submit

April 17, 2014

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Percentage of root coverage

    6 months

Secondary Outcomes (1)

  • Esthetic

    6 months

Study Arms (2)

Connective tissue graft (CTG)

SHAM COMPARATOR

The gingival recession defects were treated by connective tissue graft surgical procedure and received the sham application os low-intensity laser therapy.

Procedure: Connective tissue graft

Connective tissue graft plus laser (CTG+L)

EXPERIMENTAL

The gingival recession defects were treated by connective tissue graft associated with the application of a LILT protocol

Procedure: Connective tissue graft

Interventions

Connective tissue graftPROCEDURE

Periodontal surgical technique to treat gingival recessions

Connective tissue graft (CTG)Connective tissue graft plus laser (CTG+L)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presenting Miller class I or II gingival recession in the maxillary canines or premolars;
  • visible cemento-enamel junction (CEJ) in the teeth included in the study and pulp vitality;
  • patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  • patients older than 18 years old;
  • probing depth ˂ 3 mm in the included teeth; 6) patients who agreed to participate and signed an informed consent form

You may not qualify if:

  • patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure
  • patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
  • smokers or pregnant women
  • patients who underwent periodontal surgery in the area of interest; and 5) patients with orthodontic therapy in progress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNESP - ICT Odontologia São José dos Campos

São José dos Campos, São Paulo, 12243-300, Brazil

Location

Related Publications (3)

  • Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.

    PMID: 22092477BACKGROUND

  • Santamaria MP, Fernandes-Dias SB, Araujo CF, Lucas da Silva Neves F, Mathias IF, Rebelato Bechara Andere NM, Neves Jardini MA. 2-Year Assessment of Tissue Biostimulation With Low-Level Laser on the Outcomes of Connective Tissue Graft in the Treatment of Single Gingival Recession: A Randomized Clinical Trial. J Periodontol. 2017 Apr;88(4):320-328. doi: 10.1902/jop.2016.160391. Epub 2016 Nov 11.

    PMID: 27834120DERIVED

  • Fernandes-Dias SB, de Marco AC, Santamaria M Jr, Kerbauy WD, Jardini MA, Santamaria MP. Connective tissue graft associated or not with low laser therapy to treat gingival recession: randomized clinical trial. J Clin Periodontol. 2015 Jan;42(1):54-61. doi: 10.1111/jcpe.12328. Epub 2014 Dec 17.

    PMID: 25363203DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Stephanie B Fernandes-Dias, DDS, Ms

    UPECLIN HC FM Botucatu Unesp

    STUDY CHAIR

  • Maria Aparecida N Jardini, PhD

    UPECLIN HC FM Botucatu Unesp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

April 21, 2014

Record last verified: 2014-04

Locations

BR(1)